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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name resin, denture, relining, repairing, rebasing
510(k) Number K122348
Device Name QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
Applicant
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
3 RUE LOUIS NEEL
ST. EGREVE,  FR 38120
Applicant Contact MANH-QUYNH CHU
Correspondent
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
3 RUE LOUIS NEEL
ST. EGREVE,  FR 38120
Correspondent Contact MANH-QUYNH CHU
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBF   EBG  
Date Received08/03/2012
Decision Date 10/15/2012
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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