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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K051636
Device Name CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
Applicant
ALTATEC GMBH
520 SOUTH ROCK BLVD.
RENO,  NV  89502
Applicant Contact TINA STEFFANIE-OAK
Correspondent
ALTATEC GMBH
520 SOUTH ROCK BLVD.
RENO,  NV  89502
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/20/2005
Decision Date 02/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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