Orthodontics Bracket— 510(k) K150141

Substantially Equivalent

Speed Dental Co., Ltd.

FDA 510(k) clearance K150141 for Orthodontics Bracket, Substantially Equivalent on 2015-10-23. Applicant: Speed Dental Co., Ltd.. Device class: 2.

Clearance details

Applicant: Speed Dental Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2015-01-22
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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