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510(k) K232673

Device
Dental Glass Ceramics
Applicant
Chengdu Besmile Medical Technology Co., Ltd.
510(k) number
K232673
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-23
Date received
2023-09-01
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
Moushan Liu
Address
#9,Sec.2, Shengwucheng N. Rd. Chengdu Tianfu International Bio-Town, Shuangliu District Chengdu CN 610200 610200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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