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.. Device class: 2.

Clearance details

Applicant: Datum Dental, Ltd.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
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 ↗

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