Cleared Traditional

K923236 - TRIAD INLAY COMPOSITE

K923236 is the FDA 510(k) clearance for TRIAD INLAY COMPOSITE by Dentsply Intl.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K923236 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
72d
Days
Class 2
Risk

K923236 is an FDA 510(k) clearance for the TRIAD INLAY COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 72 days - a notably fast clearance cycle.

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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K923236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date September 11, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
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 590
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K923236.
CLIP
K926418 · Voco GmbH · Mar 1993
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K926074 · Pulpdent Corp. · Mar 1993
BISCO D/C RESINOMER
K924151 · Bisco, Inc. · Dec 1992
COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
K921407 · Ultradent Products, Inc. · Sep 1992
ENAMEL AND PORCELAIN ETCH PRODUCT LINE
K921409 · Ultradent Products, Inc. · Sep 1992
ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE
K921598 · Ultradent Products, Inc. · Sep 1992