ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY— 510(k) K060332

Name: FDA 510(k) clearance K060332
Creator: U.S. Food and Drug Administration
Published: 2006-03-29

Substantially Equivalent

Isotis NV

FDA 510(k) clearance K060332 for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY, Substantially Equivalent on 2006-03-29. Applicant: Isotis NV. Device class: 2.

Clearance details

Applicant: Isotis NV
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2006-02-09
Decision date: 2006-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bilthoven, NL

Download summary PDF View on FDA.gov ↗

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