DYNAGRAFT II DENTAL— 510(k) K043573

Name: FDA 510(k) clearance K043573
Creator: U.S. Food and Drug Administration
Published: 2005-07-29

Substantially Equivalent

Isotis Orthobiologics, Inc.

FDA 510(k) clearance K043573 for DYNAGRAFT II DENTAL, Substantially Equivalent on 2005-07-29. Applicant: Isotis Orthobiologics, Inc.. Device class: 2.

Clearance details

Applicant: Isotis Orthobiologics, Inc.
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2004-12-27
Decision date: 2005-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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