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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 K885133
Device Name APACERAM ARTIFICIAL DENTAL IMPLANT
Applicant
Asahi Optical Co. C/O Rosati Associates, P.C.
Attorney & Counselor At Law
31815 Southfield Rd. - #15
Birmingham,  MI  48009
Applicant Contact URSU, DDS
Correspondent
Asahi Optical Co. C/O Rosati Associates, P.C.
Attorney & Counselor At Law
31815 Southfield Rd. - #15
Birmingham,  MI  48009
Correspondent Contact URSU, DDS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/12/1988
Decision Date 09/05/1989
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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