CLEARFIL TRI-S BOND SINGLE DOSE— 510(k) K051796

Name: FDA 510(k) clearance K051796
Creator: U.S. Food and Drug Administration
Published: 2005-08-09

Substantially Equivalent

Kuraray Medical Kurashiki Plant

FDA 510(k) clearance K051796 for CLEARFIL TRI-S BOND SINGLE DOSE, Substantially Equivalent on 2005-08-09. Applicant: Kuraray Medical Kurashiki Plant. Device class: 2.

Clearance details

Applicant: Kuraray Medical Kurashiki Plant
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2005-07-05
Decision date: 2005-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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