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)
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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.

View all White Peaks Dental Systems GmbH & Co. KG devices

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
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 127d · 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 118
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