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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 K933705
Device Name LAMINOSS DENTAL IMPLANT
Applicant
Impladent , Ltd.
198-45 Foothill Ave.
Hollis,  NY  11423
Applicant Contact MAURICE VALEN
Correspondent
Impladent , Ltd.
198-45 Foothill Ave.
Hollis,  NY  11423
Correspondent Contact MAURICE VALEN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/30/1993
Decision Date 06/24/1996
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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