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510(k) K230487

Device
Dental Lithium Disilicate Glass-Ceramic
Applicant
Fuzhou Rick Brown Biomaterials Co., Ltd.
510(k) number
K230487
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-03
Date received
2023-02-23
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
Zhong Huang
Address
The First And Second Floors Of R&D Bldg., Jiecheng Industrial Park, #36 Houshan Zhaishan, Nan Fuzhou CN 350100 350100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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