CHALLENGE II - PASTE ADHESIVE— 510(k) K923399

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K923399 for CHALLENGE II - PASTE ADHESIVE, Substantially Equivalent on 1992-10-27. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1992-07-10
Decision date: 1992-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, 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.