EMPRESS DIRECT— 510(k) K090701

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K090701 for EMPRESS DIRECT, Substantially Equivalent on 2009-04-29. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant
Ivoclar Vivadent, Inc.
Product code
Code EBF
Device class
Class 2
Regulation
21 CFR 872.3690
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Amherst, NY, US
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