OSSATURA DENTAL— 510(k) K031813

Substantially Equivalent

Isotis NV

FDA 510(k) clearance K031813 for OSSATURA DENTAL, Substantially Equivalent on 2004-08-20. Applicant: Isotis NV. Device class: 2.

Clearance details

Applicant: Isotis NV
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2003-06-12
Decision date: 2004-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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