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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K000065
Device Name CAMLOG CYLINDER IMPLANT SYSTEM
Applicant
Altatec Biotechnologies
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact R.J. SLOMOFF
Correspondent
Altatec Biotechnologies
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact R.J. SLOMOFF
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/10/2000
Decision Date 01/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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