510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063228Substantially Equivalent

Surface Coat

Kuraray America, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063228 is the FDA 510(k) clearance record for SURFACE COAT, a class II device, cleared for Kuraray America, Inc. on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 11 510(k) clearances for Kuraray America, Inc., from to . As of , FDA records show no recalls naming K063228.

Clearance record

Decision date
Received
(44 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Kuraray America, Inc. 600 Lexington Ave. 26th Floor, New York NY
510(k) summary
Summary PDF
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