FDA.reportPublic FDA data

510(k) K250872

Device
Bioline Dental Implant System
Applicant
Bioline Dental Implant Systems, Ltd.
510(k) number
K250872
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-18
Date received
2025-03-24
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
N

Applicant Contact#

Contact
Asher Ohayon
Address
1 Haella St. Tefen Industrial Park Pob 70 Migdal Tefen IL 2495900 2495900

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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