BOND BONE— 510(k) K083858

Substantially Equivalent

Augma Biomaterials, Ltd.

FDA 510(k) clearance K083858 for BOND BONE, Substantially Equivalent on 2009-03-17. Applicant: Augma Biomaterials, Ltd.. Device class: 2.

Clearance details

Applicant: Augma Biomaterials, Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2008-12-24
Decision date: 2009-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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