PANASIL INITIAL CONTACT AND PANASIL TRAY— 510(k) K083701

Name: FDA 510(k) clearance K083701
Creator: U.S. Food and Drug Administration
Published: 2009-01-09

Substantially Equivalent

Kettenbach GmbH & Co. KG

FDA 510(k) clearance K083701 for PANASIL INITIAL CONTACT AND PANASIL TRAY, Substantially Equivalent on 2009-01-09. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Kettenbach GmbH & Co. KG
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2008-12-15
Decision date: 2009-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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