FDA.report

510(k) K250123

Device
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
Applicant
Hager& Meisinger GmbH
510(k) number
K250123
Product code
DZL
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-29
Date received
2025-01-17
Regulation
872.4880
Classification name
Screw, Fixation, Intraosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Wiebke Eckhardt
Address
Hansemannstr. 10 Neuss DE 41468 41468

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DZL

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