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510(k) K230438

Device
URIS Smart Path Implant System & Prosthetic
Applicant
Truabutment, Inc.
510(k) number
K230438
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-29
Date received
2023-02-21
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
Ki Yoon Nam
Address
17666 Fitch Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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