FDA.reportPublic FDA data

510(k) K223742

Device
Dental Ceramic Blocks
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) number
K223742
Product code
EBF
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-08
Date received
2022-12-14
Regulation
872.3690
Classification name
Material, Tooth Shade, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chen Yingying
Address
# 9 Dushan Rd., Economic And Technological Development Zone Qinhuangdao CN 066000 066000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBF#

510(k), Device, Applicant table
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