Cleared Abbreviated

K123929 - BEGOPAL+

K123929 is an FDA 510(k) clearance for BEGOPAL+, manufactured by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO. The device is a Class 2 Dental device with product code EJH cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K123929 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
84d
Days
Class 2
Risk

K123929 is an FDA 510(k) clearance for the BEGOPAL+. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (Bremen, DE). The FDA issued a Cleared decision on March 14, 2013 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO devices

FDA 510(k) Submission Details - K123929

510(k) Number K123929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2012
Decision Date March 14, 2013
Days to Decision 84 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 87
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K123929.
CONTINUM V
K040180 · Aalba Dent, Inc. · Mar 2004
CONTINUM
K040179 · Aalba Dent, Inc. · Mar 2004
VERASOFT ES
K033356 · Aalba Dent, Inc. · Dec 2003
KAVO EVEREST TITANBLANK
K024214 · Kavo America · Mar 2003
4 ALL (DW286A)
K020253 · Ivoclar Vivadent, Inc. · Apr 2002
D.SIGN 15 (DW286 B)
K020898 · Ivoclar Vivadent, Inc. · Mar 2002