DW243-64— 510(k) K923644

Substantially Equivalent

Ivoclar USA, Inc.

FDA 510(k) clearance K923644 for DW243-64, Substantially Equivalent on 1992-11-04. Applicant: Ivoclar USA, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar USA, Inc.
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1992-07-21
Decision date: 1992-11-04
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.