STRAUMANN EXTRAORAL IMPLANT SYSTEM— 510(k) K990458

Name: FDA 510(k) clearance K990458
Creator: U.S. Food and Drug Administration
Published: 1999-04-16

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K990458 for STRAUMANN EXTRAORAL IMPLANT SYSTEM, Substantially Equivalent on 1999-04-16. Applicant: Straumann USA. Device class: 1.

Clearance details

Applicant: Straumann USA
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1999-02-12
Decision date: 1999-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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