510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862557Substantially Equivalent

Austenal Acusoft Soft Liner

Austenal Dental, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862557 is the FDA 510(k) clearance record for AUSTENAL ACUSOFT SOFT LINER, a class II device, cleared for Austenal Dental, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 19 510(k) clearances for Austenal Dental, Inc., from to . As of , FDA records show no recalls naming K862557.

Clearance record

Decision date
Received
(231 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Austenal Dental, Inc. 5101 S. Keeler Ave., Chicago IL
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260