Cleared Traditional

K935151 - HYDROCOLLOID HEATING UNIT

K935151 is the FDA 510(k) clearance for HYDROCOLLOID HEATING UNIT by Centrix, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K935151 · Centrix, Inc. · Dental device
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Apr 1994
Decision
158d
Days
Class 2
Risk

K935151 is an FDA 510(k) clearance for the HYDROCOLLOID HEATING UNIT. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on April 4, 1994 after a review of 158 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 K935151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date April 04, 1994
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
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 K935151.
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
K940860 · Ultradent Products, Inc. · May 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
SUPERGEL/SUPPRESSED DUST
K940402 · Harry J. Bosworth Co. · Mar 1994
EXTRUDE
K940379 · Sybron Dental Specialties, Inc. · Mar 1994
EXA BITE REGISTRATION MATERIAL
K933206 · GC America, Inc. · Sep 1993