OSSIX BONE— 510(k) K163714

Substantially Equivalent

Datum Dental, Ltd.

FDA 510(k) clearance K163714 for OSSIX BONE, Substantially Equivalent on 2017-07-18. Applicant: Datum Dental, Ltd.. Device class: 2.

Clearance details

Applicant: Datum Dental, Ltd.
Product code: Code NPM
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2016-12-30
Decision date: 2017-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lod, IL

Download summary PDF View on FDA.gov ↗

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