Z BOND, PRELUDE ONE— 510(k) K111876

Substantially Equivalent

Danville Materials, Inc.

FDA 510(k) clearance K111876 for Z BOND, PRELUDE ONE, Substantially Equivalent on 2011-09-21. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Ramon, CA, US
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