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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 K981997
Device Name POSI-STOP/POSI-TRAC SYSTEM
Applicant
The Dental Medical Device Co., LLC
39 Aynsley Ct.
Montville,  NJ  07045
Applicant Contact MARCI BLOOM
Correspondent
The Dental Medical Device Co., LLC
39 Aynsley Ct.
Montville,  NJ  07045
Correspondent Contact MARCI BLOOM
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/08/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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