LYTHOS DIGITAL IMPRESSION SYSTEM— 510(k) K141611

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K141611 for LYTHOS DIGITAL IMPRESSION SYSTEM, Substantially Equivalent on 2014-12-05. 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: 2014-06-16
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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