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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 K070084
Device Name MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
Applicant
Est. Anthogyr
164 Rue Des Trois Lacs
Sallanches,  FR 74700
Applicant Contact ERIC GENEVE
Correspondent
Est. Anthogyr
164 Rue Des Trois Lacs
Sallanches,  FR 74700
Correspondent Contact ERIC GENEVE
Regulation Number872.4200
Classification Product Code
EFA  
Date Received01/09/2007
Decision Date 03/08/2007
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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