DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE— 510(k) K122065

Name: FDA 510(k) clearance K122065
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K122065 for DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE, Substantially Equivalent on 2013-02-08. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code NOF
Device class: Class 2
Regulation: 21 CFR 872.3661
Advisory panel: Dental
Date received: 2012-07-13
Decision date: 2013-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, 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.