FDA.reportPublic FDA data

510(k) K231687

Device
Gradual Dental Zirconia Blank
Applicant
Liaoning Upcera Co., Ltd.
510(k) number
K231687
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-07
Date received
2023-06-09
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
Li Luo
Address
#122 Xianghuai Rd., Economic Development Zone Benxi CN 117004 117004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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