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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K081017
Device Name TEMPLATE AND COUNTER-FIT
Applicant
Clinician'S Choice Dental Products, Inc.
1980 Hyde Park Rd.
London, Ontario,  CA N6H 5L9
Applicant Contact JEANETTE SMITH
Correspondent
Clinician'S Choice Dental Products, Inc.
1980 Hyde Park Rd.
London, Ontario,  CA N6H 5L9
Correspondent Contact JEANETTE SMITH
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/09/2008
Decision Date 08/04/2008
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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