FDA.report

510(k) K253341

Device
Custom Abutments AS
Applicant
Medentika GmbH
510(k) number
K253341
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-23
Date received
2025-09-30
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
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
Alexandra Schulz
Address
Hammweg 8-10 Huegelsheim DE 76549 76549

FDA Registration Numbers

Source Documents

510(k) summary PDF

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