INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016— 510(k) K100633

Substantially Equivalent

D B Orthodontics, Ltd.

FDA 510(k) clearance K100633 for INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016, Substantially Equivalent on 2010-04-01. Applicant: D B Orthodontics, Ltd..

Clearance details

Applicant: D B Orthodontics, Ltd.
Product code: Code OAT
Advisory panel: Dental
Date received: 2010-03-05
Decision date: 2010-04-01
Decision: Substantially Equivalent
Clearance type: Special
Location: West Yorkshire, GB

Download summary PDF View on FDA.gov ↗

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.