PRELUDE— 510(k) K040952

Substantially Equivalent

Danville Materials, Inc.

FDA 510(k) clearance K040952 for PRELUDE, Substantially Equivalent on 2004-06-29. Applicant: Danville Materials, Inc.. Device class: 2.

Clearance details

Applicant: Danville Materials, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2004-04-12
Decision date: 2004-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, 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.