Cleared Traditional

K952728 - RETRAC

K952728 is an FDA 510(k) clearance for RETRAC, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K952728 · Centrix, Inc. · Dental device
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Sep 1995
Decision
107d
Days
Class 2
Risk

K952728 is an FDA 510(k) clearance for the RETRAC. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 107 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K952728

510(k) Number K952728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1995
Decision Date September 29, 1995
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

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 308
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K952728.
DEGUPRINT
K955465 · Degussa Corp. · Dec 1995
IMPREGUM PENTA
K954192 · Espe GmbH & Co. Kg. · Dec 1995
MICROGLISS
K954180 · Espe GmbH & Co. Kg. · Nov 1995
AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
K954223 · American Dental Products, Inc. · Sep 1995
DENTRAY II PLUS TRAY ADHESIVE
K952930 · Confi-Dental Products Co. · Sep 1995
RAMITEC PENTA
K952693 · Espe GmbH & Co. Kg. · Aug 1995