GEM ORTHODONTIC BRACKET— 510(k) K870536

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K870536 for GEM ORTHODONTIC BRACKET, Substantially Equivalent on 1987-02-19. Applicant: Ormco Corp.. Device class: 1.

Clearance details

Applicant: Ormco Corp.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1987-02-09
Decision date: 1987-02-19
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.