J1 ATTACHMENT (ORTHODONTIC APPLIANCE)— 510(k) K891982

Name: FDA 510(k) clearance K891982
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

T.M.K. Dental Products

FDA 510(k) clearance K891982 for J1 ATTACHMENT (ORTHODONTIC APPLIANCE), Substantially Equivalent on 1989-07-14. Applicant: T.M.K. Dental Products. Device class: 1.

Clearance details

Applicant: T.M.K. Dental Products
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1989-03-28
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castro Valley, 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.