RESILIENCE M5 PROTECTION PLUS

Adhesive, Bracket And Tooth Conditioner, Resin

CONFI-DENTAL PRODUCTS CO.

The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Resilience M5 Protection Plus.

Pre-market Notification Details

Device IDK955329
510k NumberK955329
Device Name:RESILIENCE M5 PROTECTION PLUS
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville,  CO  80027 -3028
ContactSharon A Lutton
CorrespondentSharon A Lutton
CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville,  CO  80027 -3028
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-20
Decision Date1996-03-28

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