PANAVIA SA Cement Plus Automix +5 more— 510(k) K142625

Name: FDA 510(k) clearance K142625
Creator: U.S. Food and Drug Administration
Published: 2015-01-27

Substantially Equivalent

Kuraray Noritake Dental, Inc.

FDA 510(k) clearance K142625 for PANAVIA SA Cement Plus Automix +5 more, Substantially Equivalent on 2015-01-27. Applicant: Kuraray Noritake Dental, Inc.. Device class: 2.

Clearance details

Device name as filed: PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)
Applicant: Kuraray Noritake Dental, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2014-09-16
Decision date: 2015-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

Download summary PDF View on FDA.gov ↗

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