FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Yomi S Robotic System
K Number: K252376
·
Decision Oct 28, 2025
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
18
Review Days
90
Basic Information
- Device Name
- Yomi S Robotic System
- K Number
- K252376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neocis, Inc.
- Date Received
- July 30, 2025
- Decision Date
- October 28, 2025
- Product Code
- PLV
- 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 |
|---|---|---|---|
| PLV | Dental Stereotaxic Instrument | FDA class 2 | Dental |
Similar 510(k) Clearances
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Other Clearances by Neocis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251835 | Yomi Robotic System | Oct 10, 2025 | Substantially Equivalent |
| K231018 | Yomi Robotic System | Aug 14, 2023 | Substantially Equivalent |
| K222750 | Yomi Robotic System | Dec 8, 2022 | Substantially Equivalent |
| K222049 | Yomi Robotic System | Nov 4, 2022 | Substantially Equivalent |
| K211466 | Yomi Robotic System with YomiPlan Go | Jun 14, 2022 | Substantially Equivalent |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Dec 22, 2021 | Substantially Equivalent |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Jul 28, 2021 | Substantially Equivalent |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Dec 15, 2020 | Substantially Equivalent |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Dec 4, 2020 | Substantially Equivalent |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Oct 19, 2020 | Substantially Equivalent |