FDA.report

510(k) K252165

Device
ZIRCONOMER P
Applicant
Shofu Dental Corporation
510(k) number
K252165
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-28
Date received
2025-07-10
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Related Records

Applicant Contact

Contact
Malzyner Mauro
Address
1225 Stone Dr. San Marcos CA US 92078 92078

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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