Cleared Traditional

LIGHT CURE DENTURE GLAZE (K871849) - FDA 510(k) Clearance

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

K871849 · Austenal Dental, Inc. · Dental device
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Aug 1987
Decision
90d
Days
Class 2
Risk

K871849 is an FDA 510(k) clearance for the LIGHT CURE DENTURE GLAZE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Austenal Dental, Inc. devices

Submission Details

510(k) Number K871849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1987
Decision Date August 10, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 79
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K871849.
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · Dentsply Intl. · Apr 1991
LITELINE VLC SOFT RELINE
K895742 · Dentsply Intl. · Dec 1989
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983