Cleared Traditional

K123638 - PEKKTON IVORY

K123638 is the FDA 510(k) clearance for PEKKTON IVORY by Cendres & Metaux SA. It is a Class 2 Dental device (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

Submission Details

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
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.

Device Classification

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 92
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K123638.
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
MSN-006
K141562 · GC America, Inc. · Sep 2014
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
PRO-V COAT
K103514 · Bisco, Inc. · May 2011
TELIO CS INLAY & TELIO CS ONLAY
K103379 · Ivoclar Vivadent, Inc. · Feb 2011