DENTOCORE / DENTOCORE BODY— 510(k) K121769

Substantially Equivalent

Itena Clinical

FDA 510(k) clearance K121769 for DENTOCORE / DENTOCORE BODY, Substantially Equivalent on 2013-03-05. Applicant: Itena Clinical. Device class: 2.

Clearance details

Applicant: Itena Clinical
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2012-06-15
Decision date: 2013-03-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Laval, CA

Download summary PDF View on FDA.gov ↗

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