PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE— 510(k) K912171

Name: FDA 510(k) clearance K912171
Creator: U.S. Food and Drug Administration
Published: 1991-08-13

Substantially Equivalent

Jack James

FDA 510(k) clearance K912171 for PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE, Substantially Equivalent on 1991-08-13. Applicant: Jack James. Device class: 1.

Clearance details

Applicant: Jack James
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1991-05-16
Decision date: 1991-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.