ORTHODONTIC CERAMIC BRACKET— 510(k) K102561

Substantially Equivalent

Ht Co., Ltd.

FDA 510(k) clearance K102561 for ORTHODONTIC CERAMIC BRACKET, Substantially Equivalent on 2011-01-25. Applicant: Ht Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ht Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2010-09-07
Decision date: 2011-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ansan-Si, Gyeonggi-Do, 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.