Cleared Traditional

K000530 - BELLEGLASS HP ENAMEL

K000530 is the FDA 510(k) clearance for BELLEGLASS HP ENAMEL by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000530 · Sybron Dental Specialties, Inc. · Dental device
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May 2000
Decision
90d
Days
Class 2
Risk

K000530 is an FDA 510(k) clearance for the BELLEGLASS HP ENAMEL. 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 May 17, 2000 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K000530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date May 17, 2000
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K000530.
SCULPTURE FLOW
K001623 · Jeneric/Pentron, Inc. · Jul 2000
GRADIA
K001518 · GC America, Inc. · Jul 2000
SIGNUM
K001360 · J.F. Jelenko & Co., Inc. · Jun 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · Sybron Dental Specialties, Inc. · Mar 2000
BELLEGLASS HP OPACEOUS DENTIN
K000269 · Sybron Dental Specialties, Inc. · Mar 2000
BUILD-IT FR
K000211 · Jeneric/Pentron, Inc. · Mar 2000