FIRECR DENTALIMAGING SYSTEM— 510(k) K131442

Substantially Equivalent

3Disc Americas

FDA 510(k) clearance K131442 for FIRECR DENTALIMAGING SYSTEM, Substantially Equivalent on 2013-09-06. Applicant: 3Disc Americas. Device class: 2.

Clearance details

Applicant: 3Disc Americas
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2013-05-20
Decision date: 2013-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, 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.