FDA.reportPublic FDA data

510(k) K243255

Device
URIS Long Implant & Abutments
Applicant
Truabutment, Inc.
510(k) number
K243255
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-03
Date received
2024-10-15
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

Other 510(k) Records For Product Code DZE#

510(k), Device, Applicant table
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K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda2025-11-07
K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30
K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10