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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 K032448
Device Name ALTATEC CERAMIC ABUTMENT
Applicant
Altatec Biotechnologies
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact ROBERT SLOMOFF
Correspondent
Altatec Biotechnologies
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact ROBERT SLOMOFF
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/08/2003
Decision Date 08/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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