FDA.reportPublic FDA data

510(k) K240574

Device
BruxZir® Radiant
Applicant
Prismatik Dentalcraft, Inc.
510(k) number
K240574
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-20
Date received
2024-03-01
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Su Hyun Park
Address
2144 Michelson Dr. Irvine CA US 92612 92612

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K250673CERABIEN MiLaiKuraray Noritake Dental, Inc.2025-05-29
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K250393ZircaGlow & ZircaGlow HT ZirconiaUnited Zirconia2025-05-12