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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K912786
Device Name W-H TOPAIR DENTAL HANDPIECE
Applicant
Sabra-The Dental Products Group
7642 N. Kolmar Ave.
Skokie,  IL  60076
Applicant Contact HOWARD DANE
Correspondent
Sabra-The Dental Products Group
7642 N. Kolmar Ave.
Skokie,  IL  60076
Correspondent Contact HOWARD DANE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/24/1991
Decision Date 07/17/1991
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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