Cleared Traditional

K942219 - ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS

K942219 is an FDA 510(k) clearance for ALGIDENCO AND ALGIPRINT IMPRESSION MATE..., manufactured by Robert W. Bauer & Assoc., Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K942219 · Robert W. Bauer & Assoc., Inc. · Dental device
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Aug 1994
Decision
98d
Days
Class 2
Risk

K942219 is an FDA 510(k) clearance for the ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Robert W. Bauer & Assoc., Inc. (Chicago, US). The FDA issued a Cleared decision on August 12, 1994 after a review of 98 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 Robert W. Bauer & Assoc., Inc. devices

FDA 510(k) Submission Details - K942219

510(k) Number K942219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1994
Decision Date August 12, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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 327
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K942219.
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
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GC SURFLEX F
K943388 · GC America, Inc. · Sep 1994
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
CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
K940860 · Ultradent Products, Inc. · May 1994