NDX-40 ALLOY— 510(k) K040043

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K040043 for NDX-40 ALLOY, Substantially Equivalent on 2004-03-03. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2004-01-12
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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