ORTHODONTIC SCREW— 510(k) K103105

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K103105 for ORTHODONTIC SCREW, Substantially Equivalent on 2011-03-25. Applicant: Osstem Implant Co., Ltd..

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code OAT
Advisory panel: Dental
Date received: 2010-10-20
Decision date: 2011-03-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Fariless Hills, PA, 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.