SYSTEMP.CEM— 510(k) K042847

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K042847 for SYSTEMP.CEM, Substantially Equivalent on 2004-12-17. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2004-10-15
Decision date: 2004-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, 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.