FIN-S MICROIMPLANT— 510(k) K120861

Name: FDA 510(k) clearance K120861
Creator: U.S. Food and Drug Administration
Published: 2013-02-21

Substantially Equivalent

Creekside Orthodontics

FDA 510(k) clearance K120861 for FIN-S MICROIMPLANT, Substantially Equivalent on 2013-02-21. Applicant: Creekside Orthodontics. Device class: 2.

Clearance details

Applicant: Creekside Orthodontics
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2012-03-22
Decision date: 2013-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boise, ID, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAT

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K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck2026-05-19
K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device)2025-06-19
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.