Cleared Traditional

RESILIENCE M5 PROTECTION PLUS

K955329 · Confi-Dental Products Co. · Dental
Mar 1996
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K955329 is an FDA 510(k) clearance for the RESILIENCE M5 PROTECTION PLUS, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on March 28, 1996, 129 days after receiving the submission on November 20, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K955329 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date March 28, 1996
Days to Decision 129 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

Similar Devices — DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 191
Ormco? EtchFree Bonding System, Ormco? EtchFree Bonding Primer, Ormco? EtchFree Adhesive
K250015 · Ormco Corporation · Jan 2025
BracePaste Fluoride Sealant
K242537 · American Orthodontics Corp. · Aug 2024
3M? Transbond? Orthodontic Adhesive
K234043 · 3M Unitek Orthodontic Products · Dec 2023
AlignerFlow LC
K231817 · Voco GmbH · Dec 2023
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
K214054 · Tp Orthodontics, Inc. · Oct 2022
FiteBac CC OrthoSeal
K210115 · Largent Health, LLC · Jul 2021