Apinator— 510(k) K160123

Substantially Equivalent

Allen J. Moses, Dds, Ltd.

FDA 510(k) clearance K160123 for Apinator, Substantially Equivalent on 2016-07-12. Applicant: Allen J. Moses, Dds, Ltd..

Clearance details

Applicant: Allen J. Moses, Dds, Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2016-01-20
Decision date: 2016-07-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chicago, IL, 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.