ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM— 510(k) K063770

Substantially Equivalent

Alpha-Bio Tec , Ltd.

FDA 510(k) clearance K063770 for ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM, Substantially Equivalent on 2007-03-26. Applicant: Alpha-Bio Tec , Ltd..

Clearance details

Applicant: Alpha-Bio Tec , Ltd.
Product code: Code OAT
Advisory panel: Dental
Date received: 2006-12-20
Decision date: 2007-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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.