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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 K872089
Device Name APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)
Applicant
Asahi Optical Co. C/O Rosati Associates, P.C.
7115 Orchard Lake Rd.
Suite 140
West Bloomfield,  MI  48033
Applicant Contact A. D ROSATI
Correspondent
Asahi Optical Co. C/O Rosati Associates, P.C.
7115 Orchard Lake Rd.
Suite 140
West Bloomfield,  MI  48033
Correspondent Contact A. D ROSATI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/01/1987
Decision Date 08/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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