510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854957Substantially Equivalent

Austenal Dental Composite Resin

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

K854957 is the FDA 510(k) clearance record for AUSTENAL DENTAL COMPOSITE RESIN, a class II device, cleared for Austenal Dental, Inc. on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 19 510(k) clearances for Austenal Dental, Inc., from to . As of , FDA records show no recalls naming K854957.

Clearance record

Decision date
Received
(50 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Austenal Dental, Inc. 5101 S. Keeler Ave., Chicago IL
Third party review
No

Clearances, product code EBD

Trailing 12 months
1 clearance under product code EBD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260