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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 K864995
Device Name OSSEOINTEGRATED FIXTURES FOR USE IN DENTAL IMPLANT
Applicant
Vent-Plant Corporation, Inc.
1829 J.F.K. Blvd.
Philadelphia,  PA  19103
Applicant Contact RINALDI, DMD
Correspondent
Vent-Plant Corporation, Inc.
1829 J.F.K. Blvd.
Philadelphia,  PA  19103
Correspondent Contact RINALDI, DMD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/22/1986
Decision Date 02/25/1987
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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