FDA.reportPublic FDA data

510(k) K243940

Device
VITA YZ Multi Translucent
Applicant
Vita Zahnfabrik H.Rauter GmbH & Co.
510(k) number
K243940
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-21
Date received
2024-12-20
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lindsay Tilton
Address
Spitelgasse 3 Bad Sackingen DE : D-79713 : D-79713

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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