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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 K910224
Device Name THERMAPREP
Applicant
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Applicant Contact BEN JOHNSON
Correspondent
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Correspondent Contact BEN JOHNSON
Regulation Number872.3850
Classification Product Code
EKM  
Date Received01/18/1991
Decision Date 03/29/1991
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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