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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K940680
Device Name VERSADOWEL POST SYSTEM
Applicant
Dental Power, Inc.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -5600
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Dental Power, Inc.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -5600
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number872.3810
Classification Product Code
ELR  
Date Received02/10/1994
Decision Date 03/15/1994
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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