K111809

Substantially Equivalent

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

Applicant: Biomaterials Korea, Inc.
Product 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

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.