PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM— 510(k) K121804

Name: FDA 510(k) clearance K121804
Creator: U.S. Food and Drug Administration
Published: 2013-04-19

Substantially Equivalent

Itena Clinical

FDA 510(k) clearance K121804 for PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM, Substantially Equivalent on 2013-04-19. Applicant: Itena Clinical. Device class: 2.

Clearance details

Applicant: Itena Clinical
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2012-06-19
Decision date: 2013-04-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Laval, CA

Download summary PDF View on FDA.gov ↗

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