ORTHODONTIC CERAMIC BRACKETS 1.1— 510(k) K160615

Substantially Equivalent

Tomy, Inc.

FDA 510(k) clearance K160615 for ORTHODONTIC CERAMIC BRACKETS 1.1, Substantially Equivalent on 2016-08-26. Applicant: Tomy, Inc.. Device class: 2.

Clearance details

Applicant: Tomy, Inc.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2016-03-03
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midoricho, Fuchu City, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Tomy, Inc.

K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES2018-10-30
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K123094 — ORTHODONTIC CERAMIC BRACKETS2012-12-13

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