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510(k) K230108

Device
Straumann® BLC and TLC Implants
Applicant
Institut Straumann AG
510(k) number
K230108
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-14
Date received
2023-01-13
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Corinne Arimatea
Address
Peter Merian Weg 12 Basel CH CH-4002 CH-4002

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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