Cleared Traditional

K925359 - RESILIENCE ORTHODONTIC BRACKET ADHES W/...

K925359 is the FDA 510(k) clearance for RESILIENCE ORTHODONTIC BRACKET ADHES W/... by Confi-Dental Products Co.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K925359 · Confi-Dental Products Co. · Dental device
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Jul 1993
Decision
259d
Days
Class 2
Risk

K925359 is an FDA 510(k) clearance for the RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 259 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Confi-Dental Products Co. devices

Submission Details

510(k) Number K925359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date July 08, 1993
Days to Decision 259 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 127d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 115
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K925359.
SYSTEM 1
K940845 · Sybron Dental Specialties, Inc. · Mar 1994
ORMCO SYSTEM 1+ (TM)
K941015 · Ormco Corp. · Mar 1994
CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K935714 · Confi-Dental Products Co. · Jan 1994
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
K930614 · Wallace A. Erickson & Co. · Jun 1993
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283 · Jeneric/Pentron, Inc. · Dec 1992
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND
K921044 · Wallace A. Erickson & Co. · Nov 1992