Cleared Traditional

K940860 - CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS

K940860 is an FDA 510(k) clearance for CHROMACLONE COLOR CHANGING ALGINATE IMP..., manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K940860 · Ultradent Products, Inc. · Dental device
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May 1994
Decision
93d
Days
Class 2
Risk

K940860 is an FDA 510(k) clearance for the CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 93 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K940860

510(k) Number K940860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date May 27, 1994
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
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 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K940860.
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
ULTRA HYDROPHILIC ALGINAE
K943475 · Essential Dental Systems, Inc. · Aug 1994
ORTHALGENAT IMPRESSION MATERIAL
K942666 · Dentauraum, Inc. · Aug 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
HYDROCOLLOID HEATING UNIT
K935151 · Centrix, Inc. · Apr 1994
SUPERGEL/SUPPRESSED DUST
K940402 · Harry J. Bosworth Co. · Mar 1994