FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URIS Smart Path Implant System & Prosthetic
K Number: K230438
·
Decision Dec 29, 2023
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
15
Review Days
311
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Basic Information
- Device Name
- URIS Smart Path Implant System & Prosthetic
- K Number
- K230438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Truabutment, Inc.
- Date Received
- February 21, 2023
- Decision Date
- December 29, 2023
- Product Code
- DZE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Truabutment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243255 | URIS Long Implant & Abutments | Jul 3, 2025 | Substantially Equivalent |
| K241485 | TruAbutment DS; TruBase | Oct 9, 2024 | Substantially Equivalent |
| K231874 | AOT & T-L Abutment | Oct 30, 2023 | Substantially Equivalent |
| K213961 | TruAbutment DS, TruBase | Jul 14, 2022 | Substantially Equivalent |
| K203649 | TruAbutment DS, TruBase | Sep 15, 2021 | Substantially Equivalent |
| K202579 | TruAbutment DS, TruBase | Jul 8, 2021 | Substantially Equivalent |
| K201842 | TruBase S | Jun 4, 2021 | Substantially Equivalent |
| K201197 | TruAbutment DS, TruBase S | Mar 26, 2021 | Substantially Equivalent |
| K200817 | URIS OMNI Narrow System & Prosthetic | Oct 7, 2020 | Substantially Equivalent |
| K191913 | TruAbutment DS | Jun 19, 2020 | Substantially Equivalent |