OSSIX Breeze— 510(k) K212509

Substantially Equivalent

Datum Dental, Ltd.

FDA 510(k) clearance K212509 for OSSIX Breeze, Substantially Equivalent on 2022-07-18. Applicant: Datum Dental, Ltd..

Clearance details

Applicant: Datum Dental, Ltd.
Product code: Code NPL
Advisory panel: Dental
Date received: 2021-08-09
Decision date: 2022-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lod, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.