FDA.reportPublic FDA data

510(k) K220816

Device
BruxZir NOW
Applicant
Prismatik Dentalcraft, Inc.
510(k) number
K220816
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-02
Date received
2022-03-21
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
So Hyun Park
Address
2144 Michelson Dr. Irvine CA US 96212 96212

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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