Cleared Traditional

K862557 - AUSTENAL ACUSOFT SOFT LINER

K862557 is an FDA 510(k) clearance for AUSTENAL ACUSOFT SOFT LINER, manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K862557 · Austenal Dental, Inc. · Dental device
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Feb 1987
Decision
231d
Days
Class 2
Risk

K862557 is an FDA 510(k) clearance for the AUSTENAL ACUSOFT SOFT LINER. 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 February 19, 1987 after a review of 231 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 Dental, Inc. devices

FDA 510(k) Submission Details - K862557

510(k) Number K862557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date February 19, 1987
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 127d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 175
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K862557.
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
LIGHT CURE DENTURE GLAZE
K871849 · Austenal Dental, Inc. · Aug 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · Austenal Dental, Inc. · Mar 1987
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986
AUSTENAL ACUPAC HI DENTURE BASE MATERIAL
K862558 · Austenal Dental, Inc. · Jul 1986
ACRYLIC SOLDER
K861239 · Parker Laboratories, Inc. · Apr 1986