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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 K120013
Device Name TEMPSPAN CLEAR MATRIX
Original Applicant
PENTRON CLINICAL
1717 west collins avenue
orange,  CA  92867
Original Contact wendy garman
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/03/2012
Decision Date 05/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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