ORTHO IMPLANT AND ACCESSORIES— 510(k) K982509

Name: FDA 510(k) clearance K982509
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K982509 for ORTHO IMPLANT AND ACCESSORIES, Substantially Equivalent on 1998-09-30. Applicant: Straumann USA. Device class: 2.

Clearance details

Applicant: Straumann USA
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1998-07-20
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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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.