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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K090676
Device Name MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
Applicant
Anthogyr
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Applicant Contact BRAYETTE SABINE
Correspondent
Anthogyr
2237 Ave. Andre Lasquin
Sallanches,  FR 74700
Correspondent Contact BRAYETTE SABINE
Regulation Number872.4200
Classification Product Code
EFA  
Date Received03/13/2009
Decision Date 05/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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