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

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..

Clearance details

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

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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.