Cleared Traditional

ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS (K942219) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942219 · Robert W. Bauer & Assoc., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K942219.
3M PROPLUS SYSTEM
K963766 · 3M Company · Oct 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · Dentsply Intl. · Apr 1989