Cleared Traditional

K123680 - COPRANCOLOR

K123680 is an FDA 510(k) clearance for COPRANCOLOR, manufactured by White Peaks Dental Systems GmbH & Co. KG. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K123680 · White Peaks Dental Systems GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
83d
Days
Class 2
Risk

K123680 is an FDA 510(k) clearance for the COPRANCOLOR. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by White Peaks Dental Systems GmbH & Co. KG (Essen, DE). The FDA issued a Cleared decision on February 21, 2013 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

FDA 510(k) Submission Details - K123680

510(k) Number K123680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2012
Decision Date February 21, 2013
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 291
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K123680.
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