MODIFICATION TO CLEARFIL PHOTO BOND— 510(k) K012432

Name: FDA 510(k) clearance K012432
Creator: U.S. Food and Drug Administration
Published: 2001-09-04

Substantially Equivalent

Kuraray Medical, Inc.

FDA 510(k) clearance K012432 for MODIFICATION TO CLEARFIL PHOTO BOND, Substantially Equivalent on 2001-09-04. Applicant: Kuraray Medical, Inc.. Device class: 2.

Clearance details

Applicant: Kuraray Medical, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2001-07-31
Decision date: 2001-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

view all

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Kuraray Medical, Inc.

view all

K120378 — PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S2012-03-30
K120379 — PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S2012-03-30
K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK2011-10-14
K100328 — CLEARFIL MAJETY POSTERIOR2010-03-05
K092281 — CLEARFIL MAJESTY POSTERIOR PLT2009-10-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.