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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K880371
Device Name BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER
Applicant
American Biomaterials Corp.
105 Morgan Dr.
Plainsboro,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
American Biomaterials Corp.
105 Morgan Dr.
Plainsboro,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/27/1988
Decision Date 11/18/1988
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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