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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 K881662
Device Name EXPANDED CLAIMES TO OSTEOGEN(R)
Applicant
Impladent
198-45 Foothill Ave.
Hollis,  NY  11423
Applicant Contact MAURICE VALEN
Correspondent
Impladent
198-45 Foothill Ave.
Hollis,  NY  11423
Correspondent Contact MAURICE VALEN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/15/1988
Decision Date 09/01/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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