K061397

Substantially Equivalent

ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M

Applicant: Ace Surgical Supply Co., Inc.
Product code: OAT
Advisory panel: Dental
Date received: 2006-05-19
Decision date: 2006-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brockton, MA, 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.