Cleared Traditional

K030646 - BELLEGLASS POINT 4

K030646 is an FDA 510(k) clearance for BELLEGLASS POINT 4, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K030646 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
67d
Days
Class 2
Risk

K030646 is an FDA 510(k) clearance for the BELLEGLASS POINT 4. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K030646

510(k) Number K030646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2003
Decision Date May 06, 2003
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 42
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K030646.
BISCOVER LED
K051999 · Bisco, Inc. · Aug 2005
BISCOVER LV
K043168 · Bisco, Inc. · Feb 2005
PARKELL RESIN GLAZE
K040599 · Parkell, Inc. · Apr 2004
SCULPTING RESIN
K030585 · Bisco, Inc. · Apr 2003
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
K030354 · Bisco, Inc. · Feb 2003
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
K024046 · Bisco, Inc. · Feb 2003