A-Line Advanced— 510(k) K231635

Substantially Equivalent

Biocetec Co., Ltd.

FDA 510(k) clearance K231635 for A-Line Advanced, Substantially Equivalent on 2023-06-06. Applicant: Biocetec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Biocetec Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2023-06-05
Decision date: 2023-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Biocetec Co., Ltd.

K190871 — Bio-TackS Orthodontic Mini Implant2020-01-17
K182193 — S-Line2019-01-22
K163467 — C-Line Orthodontic Ceramic Bracket2017-06-14

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