Cleared Traditional

K000530 - BELLEGLASS HP ENAMEL

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

K000530 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K000530

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.

EBF Device Classification - Class 2, Special Controls

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 761
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
EZ CONNECT RESIN
K000357 · Kerr Dental Materials Center · Apr 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · Sybron Dental Specialties, Inc. · Mar 2000
BELLEGLASS HP OPACEOUS DENTIN
K000269 · Sybron Dental Specialties, Inc. · Mar 2000