510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K111975Substantially Equivalent

Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack

Kuraray Medical, Inc., Chiyoda-Ku, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111975 is the FDA 510(k) clearance record for CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK, a class II device, cleared for Kuraray Medical, Inc. on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list 42 510(k) clearances for Kuraray Medical, Inc., from to . As of , FDA records show no recalls naming K111975.

Clearance record

Decision date
Received
(94 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
Kuraray Medical, Inc. Ote Center Bld, Chiyoda-Ku, Tokyo, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLE

Trailing 12 months
8 clearances under product code KLE in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KLE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20261
March 20262
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260