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510(k) K252789

Device
Glass Ceramic
Applicant
Shenzhen Xiangtong Co., Ltd.
510(k) number
K252789
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-08
Date received
2025-09-02
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xue Gong
Address
Rm. 101,301,701,801,Bldg. 1,#110,Guanchang Rd. Dalingshan Town Dongguan CN 523800 523800

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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