TRINIA— 510(k) K133608

Substantially Equivalent

Bicon, LLC

FDA 510(k) clearance K133608 for TRINIA, Substantially Equivalent on 2014-03-14. Applicant: Bicon, LLC. Device class: 2.

Clearance details

Applicant: Bicon, LLC
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2013-11-25
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boston, MA, 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.