BONEGEN - TR— 510(k) K060285

Substantially Equivalent

Bio-Lok Intl., Inc.

FDA 510(k) clearance K060285 for BONEGEN - TR, Substantially Equivalent on 2006-03-16. Applicant: Bio-Lok Intl., Inc.. Device class: 2.

Clearance details

Applicant: Bio-Lok Intl., Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2006-02-03
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, NJ, US

Download summary PDF View on FDA.gov ↗

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