510(k) K230438
K230438 is an FDA 510(k) premarket notification submitted by Truabutment, Inc. for the device "URIS Smart Path Implant System & Prosthetic". The FDA issued a decision of Substantially Equivalent on December 29, 2023. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Truabutment, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2023
- Date Received
- February 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type