Cleared Traditional

K920534 - PORCELAIN PRIMER

K920534 is the FDA 510(k) clearance for PORCELAIN PRIMER by Confi-Dental Products Co.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K920534 · Confi-Dental Products Co. · Dental device
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Mar 1992
Decision
50d
Days
Class 2
Risk

K920534 is an FDA 510(k) clearance for the PORCELAIN PRIMER. 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 March 26, 1992 after a review of 50 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 K920534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date March 26, 1992
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 K920534.
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
K921245 · Ormco Corp. · May 1992
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
K921385 · Ormco Corp. · Apr 1992
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K914317 · Confi-Dental Products Co. · Mar 1992
SEQUENCE LIGHT CURE ADHESIVE
K914727 · Ormco Corp. · Jan 1992
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · Pulpdent Corp. · Jul 1991
PHASE II ORTHODONTIC ADHESIVE
K895523 · Reliance Orthodontic Products, Inc. · Dec 1989