Cleared Traditional

K920533 - DENTIN BONDING AGENT

K920533 is the FDA 510(k) clearance for DENTIN BONDING AGENT by Confi-Dental Products Co.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K920533 · Confi-Dental Products Co. · Dental device
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May 1993
Decision
469d
Days
Class 2
Risk

K920533 is an FDA 510(k) clearance for the DENTIN BONDING AGENT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Confi-Dental Products Co. devices

Submission Details

510(k) Number K920533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date May 19, 1993
Days to Decision 469 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
342d slower than avg
Panel avg: 127d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K920533.
BISCO D/C CORE COMPOSITE
K930405 · Bisco, Inc. · Aug 1993
VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993
CHARISMA -- MODIFIED
K932013 · Heraeus Kulzer, Inc. · Jul 1993
VIVALUX
K926556 · Ivoclar North America, Inc. · Apr 1993
CLIP
K926418 · Voco GmbH · Mar 1993
PULPDENT DENTAL BOND ENCHANCER
K926074 · Pulpdent Corp. · Mar 1993