Cleared Abbreviated

K123929 - BEGOPAL+ (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.