THE INSYNC CERAMIC SYSTEM— 510(k) K111743

Name: FDA 510(k) clearance K111743
Creator: U.S. Food and Drug Administration
Published: 2011-09-14

Substantially Equivalent

Jensen Industries, Inc.

FDA 510(k) clearance K111743 for THE INSYNC CERAMIC SYSTEM, Substantially Equivalent on 2011-09-14. Applicant: Jensen Industries, Inc.. Device class: 2.

Clearance details

Applicant: Jensen Industries, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2011-06-21
Decision date: 2011-09-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Haven, CT, 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.