IROOT SP— 510(k) K080917

Substantially Equivalent

Innovative Bioceramix, Inc.

FDA 510(k) clearance K080917 for IROOT SP, Substantially Equivalent on 2008-04-09. Applicant: Innovative Bioceramix, Inc.. Device class: 2.

Clearance details

Applicant: Innovative Bioceramix, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2008-04-01
Decision date: 2008-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, Bc, CA

Download summary PDF View on FDA.gov ↗

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