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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K900986
Device Name THERMAFIL ENDODONTIC OBTURATOR
Applicant
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Applicant Contact JOHNSON, DDS
Correspondent
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Correspondent Contact JOHNSON, DDS
Regulation Number872.3850
Classification Product Code
EKM  
Date Received03/01/1990
Decision Date 11/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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