PREVENT SEAL— 510(k) K122521

Substantially Equivalent

Itena Clinical

FDA 510(k) clearance K122521 for PREVENT SEAL, Substantially Equivalent on 2013-06-11. Applicant: Itena Clinical. Device class: 2.

Clearance details

Applicant: Itena Clinical
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 2012-08-20
Decision date: 2013-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Itena Clinical

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K162960 — TotalC-Ram2017-03-14
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K121804 — PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM2013-04-19

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