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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
Models 50 00 020, 50 10 001
Device Name QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW
Original Applicant
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
3 rue louis neel
st. egreve,  FR 38120
Original 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 (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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