IMAGINE H.E.— 510(k) K012156

Substantially Equivalent

Wieland Edelmetalle GmbH & Co.

FDA 510(k) clearance K012156 for IMAGINE H.E., Substantially Equivalent on 2001-08-16. Applicant: Wieland Edelmetalle GmbH & Co.. Device class: 2.

Clearance details

Applicant: Wieland Edelmetalle GmbH & Co.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2001-07-11
Decision date: 2001-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pforzheim, DE

Download summary PDF View on FDA.gov ↗

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