Cleared Traditional

MYERSON'S PERMASOFT SOFT RELINE MATERIAL (K933468) - FDA 510(k) Clearance

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

K933468 · Austenal, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
173d
Days
Class 2
Risk

K933468 is an FDA 510(k) clearance for the MYERSON'S PERMASOFT SOFT RELINE MATERIAL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Austenal, Inc. (Chicago, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 173 days - an extended review cycle.

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, Inc. devices

Submission Details

510(k) Number K933468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1993
Decision Date January 05, 1994
Days to Decision 173 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 127d · This submission: 173d
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 K933468.
LIQCRYLIC PRO DENTAL RESIN
K972573 · Dentsply Intl. · Sep 1997
TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · Dec 1996
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
DUAL CURE RELINE MATERIAL
K926406 · Dentsply Intl. · Mar 1993
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · Dentsply Intl. · Apr 1991
LITELINE VLC SOFT RELINE
K895742 · Dentsply Intl. · Dec 1989