Yomi Robotic System
FDA 510(k) clearance K251835 · decided 2025-10-10
Clearance details
- K-number
- K251835
- Device name
- Yomi Robotic System
- Applicant
- Neocis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-16
- Decision date
- 2025-10-10
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- PLV
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Yomi S Robotic System (K252376) | Neocis, Inc. | 2025-10-28 |
| Navident (K233563) | Claronav, Inc. | 2024-07-25 |
| Yomi Robotic System (K231018) | Neocis, Inc. | 2023-08-14 |
| Navident (K210947) | Claronav, Inc. | 2022-06-27 |
| Yomi Robotic System with YomiPlan Go (K211466) | Neocis, Inc. | 2022-06-14 |
| INLIANT Surgical Navigation System (K213392) | Navigate Surgical Technologies, Inc. | 2022-02-22 |
| Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711) | Neocis, Inc. | 2021-12-22 |
| Neocis Guidance System (NGS) with Intraoral Fiducial Array (K211129) | Neocis, Inc. | 2021-07-28 |
| Neocis Guidance System (NGS) with Patient Splints (EPS) (K203401) | Neocis, Inc. | 2020-12-15 |
| Neocis Guidance System (NGS) with Yomi Plan v2.0 (K202264) | Neocis, Inc. | 2020-12-04 |
| Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (K202100) | Neocis, Inc. | 2020-10-19 |
| Neocis Guidance System (NGS) with Patient Splints (K200805) | Neocis, Inc. | 2020-07-28 |
Recalls involving this device
No recalls on record reference this clearance.