OSSIX VOLUMAX— 510(k) K153549

Substantially Equivalent

Datum Dental, Ltd.

FDA 510(k) clearance K153549 for OSSIX VOLUMAX, Substantially Equivalent on 2016-08-04. 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: 2015-12-11
Decision date: 2016-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lod, IL

Download summary PDF View on FDA.gov ↗

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