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510(k) K223714

Device
UniFit Dental Implant System
Applicant
Adin Dental Implant Systems , Ltd.
510(k) number
K223714
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-29
Date received
2022-12-12
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
Ilana Lutvak
Address
Alon Tavor Industrial Zone P.O.B 1128 Afula IL 1811101 1811101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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