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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K024261
Device Name DENTAL PROTECTOR
Applicant
Dental Concepts, LLC
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact HOWARD HOLSTEIN
Correspondent
Dental Concepts, LLC
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact HOWARD HOLSTEIN
Classification Product Code
MQC  
Date Received12/23/2002
Decision Date 03/26/2003
Decision Substantially Equivalent (SESE)
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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