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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 K023631
Device Name ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
Applicant
ASTRA TECH, INC.
96 WEST MAIN ST.
P.O. BOX 809
NORTHBOROUGH,  MA  01532
Applicant Contact BRUCE R MANNING
Correspondent
ASTRA TECH, INC.
96 WEST MAIN ST.
P.O. BOX 809
NORTHBOROUGH,  MA  01532
Correspondent Contact BRUCE R MANNING
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/29/2002
Decision Date 11/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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