Cleared Traditional

K131664 - COPRA TEMP PMMA-DISK

K131664 is an FDA 510(k) clearance for COPRA TEMP PMMA-DISK, manufactured by White Peaks Dental Systems GmbH & Co. KG. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K131664 · White Peaks Dental Systems GmbH & Co. KG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
194d
Days
Class 2
Risk

K131664 is an FDA 510(k) clearance for the COPRA TEMP PMMA-DISK. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by White Peaks Dental Systems GmbH & Co. KG (Louisville, US). The FDA issued a Cleared decision on December 18, 2013 after a review of 194 days - an extended review 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: 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 - K131664

510(k) Number K131664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2013
Decision Date December 18, 2013
Days to Decision 194 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
66d slower than avg
Panel avg: 128d · This submission: 194d
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 174
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K131664.
MSN-006
K141562 · GC America, Inc. · Sep 2014
ARGEN PMMA
K140894 · The Argen Corporation · Jul 2014
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
K132937 · Harvest Dental Products, LLC · May 2014
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
BRIGHTGLASS BRIGHTGLASS M
K122025 · Ktk Medical Supplies GmbH · Oct 2012
K131664 · COPRA TEMP PMMA-DISK
Download PDF FDA Summary White Peaks Dental Sy…