Cleared Traditional

K935714 - CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE

K935714 is the FDA 510(k) clearance for CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE by Confi-Dental Products Co.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K935714 · Confi-Dental Products Co. · Dental device
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Jan 1994
Decision
52d
Days
Class 2
Risk

K935714 is an FDA 510(k) clearance for the CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE. 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 January 21, 1994 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Confi-Dental Products Co. devices

Submission Details

510(k) Number K935714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date January 21, 1994
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
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 K935714.
ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
K935625 · Wallace A. Erickson & Co. · Aug 1994
SYSTEM 1
K940845 · Sybron Dental Specialties, Inc. · Mar 1994
ORMCO SYSTEM 1+ (TM)
K941015 · Ormco Corp. · Mar 1994
RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
K925359 · Confi-Dental Products Co. · Jul 1993
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