TOMAS PIN— 510(k) K042965

Substantially Equivalent

Dentaurum, Inc.

FDA 510(k) clearance K042965 for TOMAS PIN, Substantially Equivalent on 2005-04-15. Applicant: Dentaurum, Inc..

Clearance details

Applicant: Dentaurum, Inc.
Product code: Code OAT
Advisory panel: Dental
Date received: 2004-10-27
Decision date: 2005-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, 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.