FDA.reportPublic FDA data

510(k) K242740

Device
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
Applicant
Liaoning Rachcera Material Technology Co., Ltd.
510(k) number
K242740
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-05
Date received
2024-09-11
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
Liang Chen
Address
#31-1-5, Chang Qingnan St., Hunnan New District Shenyang CN 110000 110000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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