Cleared Traditional

K052781 - BREFORMANCE

K052781 is an FDA 510(k) clearance for BREFORMANCE, manufactured by Bredent-Products For the Dental Technician Laborat. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K052781 · Bredent-Products For the Dental Technician Laborat · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
67d
Days
Class 2
Risk

K052781 is an FDA 510(k) clearance for the BREFORMANCE. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Bredent-Products For the Dental Technician Laborat (Tuttlingen, DE). The FDA issued a Cleared decision on December 9, 2005 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Bredent-Products For the Dental Technician Laborat devices

FDA 510(k) Submission Details - K052781

510(k) Number K052781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date December 09, 2005
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 135
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K052781.
TEMPORARY CROWN & BRIDGE RESIN
K060881 · Cosmedent, Inc. · May 2006
PROVISIONAL INLAY/ONLAY KIT
K052800 · Dmg USA, Inc. · Mar 2006
TEMPORARY CROWN AND BRIDGE MATERIAL
K060293 · Dentsply International, Inc. · Feb 2006
SYSTEMP.C&B PLUS
K042820 · Ivoclar Vivadent, Inc. · Dec 2004
PROVISO
K041886 · Scientific Pharmaceuticals, Inc. · Aug 2004
SR ADORO
K040951 · Ivoclar Vivadent, Inc. · May 2004