O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)— 510(k) K060744

Substantially Equivalent

O'Brien Dental Lab, Inc.

FDA 510(k) clearance K060744 for O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE), Substantially Equivalent on 2006-06-02. Applicant: O'Brien Dental Lab, Inc..

Clearance details

Applicant: O'Brien Dental Lab, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2006-03-20
Decision date: 2006-06-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Corvallis, OR, US

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.