SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS— 510(k) K111809

Name: FDA 510(k) clearance K111809
Creator: U.S. Food and Drug Administration
Published: 2011-09-26

Substantially Equivalent

Biomaterials Korea, Inc.

FDA 510(k) clearance K111809 for SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS, Substantially Equivalent on 2011-09-26. Applicant: Biomaterials Korea, Inc.. Device class: 2.

Clearance details

Applicant: Biomaterials Korea, Inc.
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2011-06-27
Decision date: 2011-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

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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.