ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES— 510(k) K180718

Name: FDA 510(k) clearance K180718
Creator: U.S. Food and Drug Administration
Published: 2018-10-30

Substantially Equivalent

Tomy, Inc.

FDA 510(k) clearance K180718 for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES, Substantially Equivalent on 2018-10-30. Applicant: Tomy, Inc.. Device class: 2.

Clearance details

Applicant: Tomy, Inc.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2018-03-19
Decision date: 2018-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midori-Cho, Fuchu City, JP

Download summary PDF View on FDA.gov ↗

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