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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Dental, Intraoral
510(k) Number K954790
Device Name PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
Applicant
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Applicant Contact RUSSELL VANDERSLICE
Correspondent
Tulsa Dental Products, Ltd.
5001 E. 68th St.
Tulsa,  OK  74136
Correspondent Contact RUSSELL VANDERSLICE
Regulation Number872.4130
Classification Product Code
DZA  
Date Received10/19/1995
Decision Date 01/16/1996
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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