Cleared Traditional

K935151 - HYDROCOLLOID HEATING UNIT

K935151 is an FDA 510(k) clearance for HYDROCOLLOID HEATING UNIT, 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 158-day FDA review.

K935151 · Centrix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K935151

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.

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 K935151.
ORTHALGENAT IMPRESSION MATERIAL
K942666 · Dentauraum, Inc. · 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
ALPHA-DENT
K940120 · Wallace A. Erickson & Co. · Feb 1994