510(k) K181142— Absoanchor Microimplant

Substantially Equivalent

Dentos, Inc.

Clearance details

Applicant: Dentos, Inc.
Product code: Code OAT
Advisory panel: Dental
Date received: 2018-05-01
Decision date: 2019-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

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.