Bio-TackS Orthodontic Mini Implant— 510(k) K190871

Name: FDA 510(k) clearance K190871
Creator: U.S. Food and Drug Administration
Published: 2020-01-17

Substantially Equivalent

Biocetec Co., Ltd.

FDA 510(k) clearance K190871 for Bio-TackS Orthodontic Mini Implant, Substantially Equivalent on 2020-01-17. Applicant: Biocetec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Biocetec Co., Ltd.
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2019-04-03
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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K231913 — T-FIT2024-02-08
K222245 — ACR Screw System2023-08-21

More clearances from Biocetec Co., Ltd.

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K231635 — A-Line Advanced2023-06-06
K182193 — S-Line2019-01-22
K163467 — C-Line Orthodontic Ceramic Bracket2017-06-14

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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