CLEARFIL REPAIR— 510(k) K001914

Substantially Equivalent

Kuraray Company, Ltd.

FDA 510(k) clearance K001914 for CLEARFIL REPAIR, Substantially Equivalent on 2000-08-10. Applicant: Kuraray Company, Ltd.. Device class: 2.

Clearance details

Applicant: Kuraray Company, Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2000-06-23
Decision date: 2000-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kuraray Company, Ltd.

K001913 — CLEARFIL ST OPAQUER2000-08-04
K980232 — CLEARFIL DC CEMENT1998-02-24
K965091 — TEETHMATE F-11997-03-27
K943165 — CLEARFIL PHOTO BOND1994-08-10
K943166 — CLEARFIL LINER BOND SYSTEM1994-08-10

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