Cleared Traditional

K122025 - BRIGHTGLASS BRIGHTGLASS M

K122025 is an FDA 510(k) clearance for BRIGHTGLASS BRIGHTGLASS M, manufactured by Ktk Medical Supplies GmbH. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K122025 · Ktk Medical Supplies GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
90d
Days
Class 2
Risk

K122025 is an FDA 510(k) clearance for the BRIGHTGLASS BRIGHTGLASS M. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Ktk Medical Supplies GmbH (Germering, DE). The FDA issued a Cleared decision on October 9, 2012 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 872.3770 - 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: 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.

FDA 510(k) Submission Details - K122025

510(k) Number K122025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2012
Decision Date October 09, 2012
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
38d faster than avg
Panel avg: 128d · This submission: 90d
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 182
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K122025.
COPRA TEMP PMMA-DISK
K131664 · White Peaks Dental Systems GmbH & Co. KG · Dec 2013
PEKKTON IVORY
K123638 · Cendres & Metaux SA · Feb 2013
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
K122039 · Kettenbach GmbH & Co. KG · Dec 2012
PMMA CAD/CAM DISC
K112967 · Polident D.O.O., Dental Products Industry · Aug 2012
TUFF-TEMP 2.0
K120784 · Pulpdent Corporation · Jun 2012
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
K122025 · BRIGHTGLASS BRIGHTGLASS M
Download PDF FDA Summary Ktk Medical Supplies …