SYNTEC WETALI ORTHODONTIC MINI SCREWS— 510(k) K142001

Name: FDA 510(k) clearance K142001
Creator: U.S. Food and Drug Administration
Published: 2015-03-18

Substantially Equivalent

Syntec Scientific Corporation - Taipei Office

FDA 510(k) clearance K142001 for SYNTEC WETALI ORTHODONTIC MINI SCREWS, Substantially Equivalent on 2015-03-18. Applicant: Syntec Scientific Corporation - Taipei Office. Device class: 2.

Clearance details

Applicant: Syntec Scientific Corporation - Taipei Office
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2014-07-23
Decision date: 2015-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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K231502 — Mini Screws2024-09-04
K231913 — T-FIT2024-02-08
K222245 — ACR Screw System2023-08-21

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.