Page 1

March 31, 2006

Dear Odyssey Diode Laser Owner: During the design process of the Odyssey Diode laser, our Research and Development staff became very familiar with the various different regulatory and safety requirements associated with the design of a medical laser. This included gaining a thorough understanding of the all of the specific requirements under many laser safety standards and the national regulations in the US, Canada and the European community. As evidenced by our certification through TUV Rheinland of North America, Inc. the laser meets all necessary requirements. In most state or local jurisdictions, there are no additional requirements to using a medical laser, except that it be used by or under the supervision of a licensed medical professional. However, some states and provinces have adopted laws which regulate use of the laser, including requirements for the implementation of particular safety measures by your office. In some instances registration, certification and inspection requirements also apply. As with all other regulations that affect your daily business, your office is responsible for investigating to make sure compliance with these requirements is attained. As a courtesy, and in order to provide the most useful information to our customers, we have compiled the attached list that includes contact information for each State or Provincial government office that oversees, or may oversee regulation of a medical laser. While we have strived to make sure the information is correct, since the regulatory process is ever changing, we cannot assure its complete accuracy. The list should, however, point you in the right direction for your own investigation towards compliance. Should you encounter any problems in the regulatory process or have a question, please feel free to contact me at 716-691-2260. I would be happy to assist you. Thank you for your support of the Odyssey Diode Laser. Very truly yours, IVOCLAR VIVADENT, INC.

Donna Marie Hartnett Director QA/Regulatory Affairs

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


California Alabama Kersey Whatley – Director kwhatley@adph.state.al.us (334) 206-5391 (334) 206-5387 Office of Radiation Control Alabama Dept. of Public Health RSA Tower Suite 700 201 Monroe Street Montgomery, AL 36104 Regulations: none Alaska Clyde E. Pearce - Radiological Physicist clyde_pearce@health.state.ak.us Radiological Health Program Section of State Laboratories Department of Health and Social Services State of Alaska 4500 Boniface Parkway Anchorage, AK 99507-1270 (907) 334-2107 Fax: (907) 334-2163 or 2162 Regulations: Title 18 of the Alaska Annotated Code Part 85, Art. 7, Sect. 670-730. (Oct. 1971 and Apr. 1973) and notification as required by FDA. Not actively enforced. Arizona Aubrey Godwin agodwin@arra.state.az.us (602) 255-4845, 237 (602) 437-0705 Arizona Radiation Regulation Agency 4814 S. 40th Street Phoenix, AZ 85040 Regulations: Article 14, Rules for Control of NIR, Sect. R12-1-1421 to 1444 Arkansas Bernard Bevill bbevill@health yarkansas.com 501-661-2301 Fax: 501-661-2236 Division of Radiation Control & Emergency Mgm. Department of Health 4815 W. Markham Street Slot #30 Little Rock, AR 72205 Regulations: Act 460 of the State of Arkansas Electronics Products Radiation Control Act. Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

Edgar Bailey, Director ebailey@dhs.ca.gov (916) 327-5106 Department of Health Services Radiologic Health Branch, MS 7610 P.O. Box 997414 Sacramento, CA 95899-7414 Colorado David Butcher 303-692-3069 Fax: 303-344-9989 Laboratory & Radiation Control Division Colorado Dept. of Public Health & Environment 8100 Lowry Blvd Denver, CO 80220-6928

Connecticut Edward L. Wilds, Jr Ph.D. - Director, Division of Radiation edward.wilds@po.state.ct.us http://dep.state.ct.us/ (860) 424-3029 (860) 424-4065 Radiation Control Unit Dept. of Environmental Protection 79 Elm Street Hartford, CT 06106-5127

Delaware Frieda Fisher-Tyler frieda.fisher tyler@state.de.us (302) 739-3787 (302) 739-3839 Radiation Control Office Division of Public Health P.O Box 637 Federal & Water Street Dover, DE 19903

Florida James A. Futch - Senior Health Physicist james_futch@doh.state.fl.us (850) 487-1004 (850) 487-0435 Dept. of Health, Bureau of Radiation Control 2020 Capital Circle SE, Bin C 21 Tallahassee, FL 32399-1741 Regulations: 64E-4 of FL code www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


Indiana

Georgia Barbara Belcore - Specialist Surveyor babelcor@dhr.state.ga.us 404-657-5409 Fax: 404-657-5442 Office of Regulatory Service Dept. of Human Resources 2 Peachtree N.W. - Floor 33250 Atlanta, GA 30303-3142 Regulations: Registration requirements in Chapter 31-13-1, GA Code

John Ruyack - Division Director jruack@isdh.state.in.us (317) 233-7146 (317) 233-7154 Radiological Health Section Indiana State Department of Health 2 North Meridan Street Indianapolis,IN 46204 Regulations: none Iowa

Hawaii Russell Takata - Supervisor, Radiation Section (808) 586-4700 (808) 586-5838 Noise Radiation & IAQ Branch State Department of Health 591 Ala Moana Room 133 Honolulu, HI 96813 Regulations:

Don Flater - Bureau Chief dflater@idph.state.ia.us (515) 281-3478 Fax: 515-725-0318 Bureau of Radiological Health Iowa Sept. of Public Health 401 SW 7th Street Suite D Des Moines, IA 50309-4661 Regulations: None Kansas

Idaho Grant Klokeidi - Senior Radiation Physicist hudsonr@dhw.state.id.us (208) 334-2235, 249 (208) 334-2382 Radiation Control Program Dept. of Health and Welfare 2220 Old Penitentiary Rd Boise, ID 83712 Regulations:

Kentucky

Illinois Charles Gutzman (217) 785-9921 Fax: (217) 785-9946 Illionois Energy Mangagement Agency Div. of Nuclear Safety Registration and Certification Program 1035 Outer Park Drive Springfield, IL 62704 Regulations: Regulations and registration form can be downloaded at: http://www.state.il.us/idns/html/xray/laser.asp Registration of Class 3b and 4 laser products required. At this time there are no fees associated with registration.

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Tom Conley, Chief http://www.kdhe.state.ks.us/radiation/ 785-296-6726 Fax: 785-296-0984 Bureau of Air and Radiation Dept. of Health and Environment 1000 SW Jackson St. Suite 310 Topeka, KS 66612-1366 Regulations: None

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

Dewey Crawford - Sup.Rad Producing Machine & Oper.Cert dcrawford2@mail.state.ky.us (502) 564-3700 (502) 564-6533 Radiation Health Branch Cabinet for Health Services 275 E. Main Street Frankfort, KY 40621 Regulations: None

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


Louisiana

Michigan

James Sanford - Health Physicist http://www.deq.state.la.us (504) 765-0160 (504) 765-0220 Louisiana Radiation Protection Division Dept. of Environmental Quality P.O. Box 82135 Baton Rouge, LA 70884-2135 Regulations:None. Maine Jay Hyland - Program Manager jay.hyland@state.me.us (207) 287-5677 (207) 287-4172 Division of Health Engineering Dept. of Human Services Radiation Control Program 10 State House Station Augusta, ME 04333 Regulations: None Maryland Thomas Ferguson - Program Manager Rad.Production Machine http://www.mde.state.md.us (410) 631-3301, 3302 (410) 631-3198 Radiologic Health Program Dept. of the Environment Air & Radiation Management Admin 2500 Broening Highway Baltimore, MD 21224 Regulations: None. Massachusetts Bob Watkins - Supervisor hallisey@world.std.com http://www.magnet.state.ma.us/dph/radia.htm (617) 727-6214, 2004 (617) 727-2098 Massachusetts Radiation Control Program 174 Portlant Street 5th Floor Boston, MA 02114 Regulations: 105 CMR 121.000

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

James Camburn - Chief, Radiation Safety Section jim.camburn@cis.state.mi.us http://www.cis.state.mi.us/bhs/hfs/rss/ (517) 241-1989 (517) 241-1981 Michigan Dept. of Consumer & Industry Services Bureau of Health System P.O. Box 30664 Lansing, MI 48909 Regulations: None Minnesota Susan McClanahan - Radiation Supervisor susan.mcclanahan@health.state.mn.us (651) 215-0941 (651) 215-0976 Department of Health Suite 220 121 East 7th Place P.O. Box 64975 St. Paul, MN 55164-0975 Regulations: None Mississippi Herman B. Gain, MS - Health Physicist Administrative hegaines@msdh.state.ms.us (601) 354-6657 (601) 354-6167 MSDH/Division of Radiation Health State Department of Health P.O. Box 1700 3150 Laswon Street Jackson, MS 39215-1700 Regulations: None Missouri Joe Milone - Radiologic Health analyst milonj@mail.state.mo.us (573) 751-6160 (573) 526-6946 Environment Public Health Missouri Department of Health P.O. Box 570 Jefferson City, MO 65102-0570 Regulations: none

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


Montana

New Jersey

George Eicholtz - Health Physics Supervisor http://www.dphhs.mt.gov/ (406) 444-5266 (406)444-1742 License Health Bureau Dept. of Public Health & Human Services Room C-211 P.O. Box 202951 Cogswell Building Helena, MT 59620-2951 Regulations: None Nebraska

Debra Winke - Supervisor, Non-ionizing Sect. dwenke@dep.state.nj.us (609) 984-5521 (609) 633-2210 NJ Department of Environmental Protection Non-Ionizing P.O.Box 415 25 Artic Parkway Trenton, NJ 08625-0415 Regulations: None New Mexico

Sue Semerena - Consumer Health Serv. Admin. ssemere@hhs.state.ne.us (402) 471-0928 (402) 471-0169 Health & Human Services Regulation & Licensure Public Health Services 301 Centennial Mall, S P.O. Box 95007 Lincoln, NE 68509-5007 Regulations: None

Bill Floyd - Program Manager william_floyd@nmenv.state.nm.us http://www.nmenv.state.nm.us/nmrcb/radmach.html (505) 827-1867 (505) 827-1544 New Mexico Environmental Department Hazardous Radioactive Material Bureau 2044 A Galisteo P.O. Box 26110 Santa Fe, NM 87505 Regulations: none New York

Nevada Stan Marshall - Radiation Control Specialist smarshall@govmail.state.nv.us (702) 687-5394 (702) 687-5751 Radiological Health Section Health Division 1179 Fairview Dr., Room 102 Carson City, NV 89701 Regulations: None

North Carolina

New Hampshire Wayne Johnston - Supervisor wjohnsto@dhhs.state.nh.us (603) 271-4588 (603) 225-2325 Radiation Machine Section Bureau of Radiological Health Department of Health and Human Services 6 Hazen Drive Concord, NH 03301-6527 Regulations: None

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Rita Aldrich - Principal Radiophysicist raldrich@emi.com (518) 457-1202 (518) 485-7406 NYS Dept of Labor Radiological Health Unit State Campus Building 12 Room 134A Albany, NY 12240 Regulations: 12 NYCRR Part 50

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

Amy Sawyer - Non-ionizing Coordinator amy_sawyers@mail.enr.state.nc.us (919) 571-4141, 259 (919) 571-4148 Division of Radiation Protection Dept. of Environment & Natural Resources 3825 Barrett Drive Raleigh, NC 27609 Regulations: None

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


Pennsylvania

North Dakota Ken Wanglern - Radiation Control, Manager kwangler@ranch.state.nd.us (701) 328-5188 (701) 328-5200 Division of Environmental Engineering Department of Health 1200 Missouri Avenue P.O. Box 5520 Bismark, ND 58506-5520 Regulations: None

Stuart Levin - Chief levin.stuart@a1dep.state.pa.us (717) 787-3720 (717) 783-8965 Division of Radiation Control Department of Environmental Protection P.O. Box 8469 Harrisburg, PA 17105-8469 Regulations: none (Old regulation Ch 203 was repealed 1/3/81) Rhode Island

Ohio Robert Owen - Manager Technical Services rowen@gw.odh.state.oh.us (614) 644-2727 (614) 466-0381 Bureau of Radiological Protection Department of Health 35 Chestnut Street P.O. Box 118 Columbus, OH 43266-0118 Regulations: None

Charles V. McMahon - Supervisor (401) 222-2438 (401) 222-2456 Division of Occupational & Radiological Health Department of Health Cannon Building 3 Capitol Hill, Room 206 Providence, RI 02908-5097 Regulations: none South Carolina

Oklahoma Mike Broderick - Program Supervisor mike.broderick@deqmial.state.ok.us (405) 702-5157, 5131 (405) 702-5101 Radiation and Special Hazards Service Department of Environmental Quality P.O. Box 1677 707 N. Robinson Oklahoma City, OK 73101-1677 Regulations: None

Beverly B. Patterson - Section Manager, Nonionizing Radiation patterbb@columb54.dhec.state.sc.us (803) 737-7415 (803) 737-7412 Division of Electronic Products Bureau of Radiological Health Dept. of Health & Environmental Control 2600 Bull Street Columbia, SC 29201 Regulations: written notification as required by FDA/inspection

Oregon South Dakota Darrell L. Hocken - Health Physicist darrell.l.hocken@state.or.us (503) 731-4014, 676 (503) 731-4081 Radiation Protection Services State Health Division, Dept. of Human Resources 800 Northeast Oregon #21 Suite 260 Portland, OR 97232 Regulations: None

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

Don Norton - Health Facilities SurveyorRadiation donaldn@doh.state.sd.us (605) 773-3356 (605) 773-6667 Licensure and Certificate Program South Dakota Department of Health 615 E. 4th Street Pierre, SD 57501-1700 Regulations: three day advance notification

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


Tennessee

Virginia

Robert N. Young - Health Physicist ryoung3@mail.state.tn.us (615) 532-0384 (615) 532-0385 Environment and Conservation Department of Radiological Health 3rd Fl L & C Annex 401 Church Street Nashville, TN 37243-1532 Regulations: none Texas

Washington

Barbara Taylor - Program Manager of NonIonizing Registration barb.taylor@tdh.state.tx.us http://www.tdh.state.tx.us/radiation/laser.htm (512) 834-6688, 2243 (512) 834-6716 Bureau of Radiation Control Department of Health Division of Licensing, Registration and Standards 1100 W. 49th Street Austin, TX 78756-3189 Regulations Current rules are Texas Regulations for the Control of Laser Hazards (TRCLRH), Part 50, 60 and 70. Proposed new rules will be effective approximately March or April, 1999 and will be known as 25 Texas Administrative Code (TAC) 289.301. They will be available on our website when they are in effect. Utah Phillip Griffin - Health Physicist pgriffin@deq.state.ut.us (801) 536-4261 (801) 533-4097 Division of Radiation Control Dept of Environmental Quality 168 North 1950 West P.O. Box 144850 Salt Lake City, UT 84114-4850 Regulations: advance notification Vermont Paul Clemons - Rad. & Pub. Health Spec. (802) 865-7731 (802) 865-7745 Division of Occupational & Radiological Health Department of Health 108 Cherry Street P.O. Box 70 Burlington, VT 05402

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Leslie Foldesi - Program Director lfoldesi@vdh.state.va.us http://www.vdh.state.va.us/rad/index.htm (804) 786-5932 (804) 786-6979 Bureau of Radiological Health 1500 E. Main Street Suite 240 Richmond, VA 23219 Regulations: advance notification

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

Mike Odlaug - X-Ray Manager MAO0303@hub.doh.wa.gov http://www.doh.wa.gov/ehp/rp/ Phone: 800-299-9729 Fax: 360-236-2266 X-Ray Control Department of Health/Radiation Protection 1511 3rd Ave. Suite 700 Seattle, WA 98101-1632 Regulations: State rules Ch. 296-62-09005 WAC. Light shows Advance written notification West Virginia Beattie DeBord - Chief, Rad. Health (304) 558-3526 (304) 558-0524 Office of Environmental Health Services Radiation Toxics & Indoor Division 815 Quarrier Street Suite 418 Charleston, WV 25301 Regulations: advance written notification Wisconsin Mark C. Bunge - Supervisor bungema@dhfs.state.wi.us (608) 267-4784 (608)267-4799 Radiation Protection Section Division of Public Health P.O. Box. 309 Madison, WI 53701-0309 Regulations: courtesy written notification

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com


Wyoming Debi Nelson dnelso@missc.state.wy.us (307) 377-6015 Department of Health/Preventative Medicine 4th Floor Hathaway Building Cheyenne, WY 82002-0710 Regulations: courtesy written notification District of Columbia Norma Stewart - Acting Chief redrx@erols.com (202) 727-7218 (202) 727-7728 Bureau of Food, Drug and Radiation Protection Dept. of Health 614 H Street, NW, Room 1016 Washington, D.C. 20001 Regulations: 15 days advance written notification

CANADA Alberta College of Physicians and Surgeons of Alberta Adora Okoye at (780) 970-6243, aokoye@cpsa.ab.ca http://www.cpsa.ab.ca/facilitiesaccreditation/lasers.asp 900 Manulife Place, 10180-101 St NW, Edmonton, Alberta, Canada T5J 4P8

Regulations: Radiation Control Act; registration/certification required

Manitoba Workplace Safety and Health Division of the Manitoba Department of Labour 401 York Avenue, 2nd Floor, Winnipeg, MB R3C 0P8 CANADA 204-945-5765 Web Site: www.gov.mb.ca/labour/safety Regulations: none

Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285

www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com

Microsoft Word - State and Province Regualtions.doc  

Should you encounter any problems in the regulatory process or have a question, please feel free to contact me at 716-691-2260. I would be h...

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