Cleared Traditional

K152826 - NoCord

K152826 is the FDA 510(k) clearance for NoCord by Centrix, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K152826 · Centrix, Inc. · Dental device
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May 2016
Decision
241d
Days
Class 2
Risk

K152826 is an FDA 510(k) clearance for the NoCord. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on May 27, 2016 after a review of 241 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Centrix, Inc. devices

Submission Details

510(k) Number K152826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date May 27, 2016
Days to Decision 241 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 127d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K152826.
PEAK NS033CF, PEAK NS017CF
K180565 · Neosil Co., Ltd. · Jun 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562 · Dreve Dentamid GmbH · Apr 2018
HySil Impression Materials
K170736 · Osstem Implant Co., Ltd. · Jun 2017
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · Osstem Implant Co., Ltd. · Sep 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · Ivoclar Vivadent, Inc. · Apr 2015
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012