CLEARARCH— 510(k) K101676

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K101676 for CLEARARCH, Substantially Equivalent on 2010-09-13. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2010-06-15
Decision date: 2010-09-13
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.