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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 K060075
Device Name FIBER-METAL POST
Applicant
Foremost Dental, LLC
5 Whitcomb Ave.
Ayer,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
Foremost Dental, LLC
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3810
Classification Product Code
ELR  
Date Received01/10/2006
Decision Date 03/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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