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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 K954012
Device Name DISPOSABLE PROPHY HANDPIECE
Applicant
Denticator Intl., Inc.
11330 Sunrise Park Dr., #A
Rancho Cordova,  CA  95742
Applicant Contact LESLIE ANDERSON
Correspondent
Denticator Intl., Inc.
11330 Sunrise Park Dr., #A
Rancho Cordova,  CA  95742
Correspondent Contact LESLIE ANDERSON
Regulation Number872.4200
Classification Product Code
EFB  
Date Received08/25/1995
Decision Date 11/08/1995
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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