INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA— 510(k) K142043

Name: FDA 510(k) clearance K142043
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Substantially Equivalent

Jensen Industries, Inc.

FDA 510(k) clearance K142043 for INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA, Substantially Equivalent on 2014-12-18. 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: 2014-07-28
Decision date: 2014-12-18
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.