PRELUDE ONE— 510(k) K090106

Substantially Equivalent

Danville Materials, Inc.

FDA 510(k) clearance K090106 for PRELUDE ONE, Substantially Equivalent on 2009-03-31. 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: 2009-01-01
Decision date: 2009-03-31
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.