Cleared Traditional

K123638 - PEKKTON IVORY

K123638 is an FDA 510(k) clearance for PEKKTON IVORY, manufactured by Cendres & Metaux SA. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K123638 · Cendres & Metaux SA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
87d
Days
Class 2
Risk

K123638 is an FDA 510(k) clearance for the PEKKTON IVORY. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Cendres & Metaux SA (Biel/Bienne, CH). The FDA issued a Cleared decision on February 21, 2013 after a review of 87 days - a notably fast clearance 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: 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 Cendres & Metaux SA devices

FDA 510(k) Submission Details - K123638

510(k) Number K123638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2012
Decision Date February 21, 2013
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K123638.
ARGEN PMMA
K140894 · The Argen Corporation · Jul 2014
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
K132937 · Harvest Dental Products, LLC · May 2014
COPRA TEMP PMMA-DISK
K131664 · White Peaks Dental Systems GmbH & Co. KG · Dec 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
PMMA CAD/CAM DISC
K112967 · Polident D.O.O., Dental Products Industry · Aug 2012