Cleared Traditional

K000269 - BELLEGLASS HP OPACEOUS DENTIN

K000269 is the FDA 510(k) clearance for BELLEGLASS HP OPACEOUS DENTIN by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K000269 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
55d
Days
Class 2
Risk

K000269 is an FDA 510(k) clearance for the BELLEGLASS HP OPACEOUS DENTIN. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 55 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K000269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2000
Decision Date March 23, 2000
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
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 479
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K000269.
SIGNUM
K001360 · J.F. Jelenko & Co., Inc. · Jun 2000
BELLEGLASS HP ENAMEL
K000530 · Sybron Dental Specialties, Inc. · May 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · Sybron Dental Specialties, Inc. · Mar 2000
BUILD-IT FR
K000211 · Jeneric/Pentron, Inc. · Mar 2000
ARABESK FLOW
K994304 · Voco GmbH · Feb 2000
ARABESK TOP
K994268 · Voco GmbH · Feb 2000