FDA.reportPublic FDA data

510(k) K240882

Device
BruxZir® Esthetic
Applicant
Prismatik Dentalcraft, Inc.
510(k) number
K240882
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-01
Date received
2024-04-01
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
So Hyun Park
Address
2144 Michelson Dr. Irvine CA US 92612 92612

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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