FDA.reportPublic FDA data

510(k) K250176

Device
DAND Dental Implant System
Applicant
D.A.N.D. Metal Industries North, Ltd.
510(k) number
K250176
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-21
Date received
2025-01-22
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
Yossi Nahon
Address
North P.O. B. 51 Migdal Tefen IL 2495900 2495900

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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