PLV — Dental Stereotaxic Instrument Class II
FDA product code PLV covers "Dental Stereotaxic Instrument", a Class II medical device regulated under 21 CFR 872.4120. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLV
- Device Class
- Class II
- Regulation Number
- 872.4120
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252376 | neocis | Yomi S Robotic System | October 28, 2025 |
| K251835 | neocis | Yomi Robotic System | October 10, 2025 |
| K233563 | claronav | Navident | July 25, 2024 |
| K231018 | neocis | Yomi Robotic System | August 14, 2023 |
| K210947 | claronav | Navident | June 27, 2022 |
| K211466 | neocis | Yomi Robotic System with YomiPlan Go | June 14, 2022 |
| K213392 | navigate surgical technologies | INLIANT Surgical Navigation System | February 22, 2022 |
| K210711 | neocis | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | December 22, 2021 |
| K211129 | neocis | Neocis Guidance System (NGS) with Intraoral Fiducial Array | July 28, 2021 |
| K203401 | neocis | Neocis Guidance System (NGS) with Patient Splints (EPS) | December 15, 2020 |
| K202264 | neocis | Neocis Guidance System (NGS) with Yomi Plan v2.0 | December 4, 2020 |
| K202100 | neocis | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | October 19, 2020 |
| K200805 | neocis | Neocis Guidance System (NGS) with Patient Splints | July 28, 2020 |
| K200662 | x-nav technologies | X-Guide® Surgical Navigation System | May 21, 2020 |
| K200348 | neocis | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | May 8, 2020 |
| K192579 | x-nav technologies | X-Guide Surgical Navigation System | February 3, 2020 |
| K191363 | neocis | Neocis Planning Software Application (NPSA) for 3rd Party PCs | October 2, 2019 |
| K191605 | neocis | Neocis Guidance System (NGS) | September 11, 2019 |
| K182776 | neocis | Neocis Guidance System | December 21, 2018 |
| K173402 | neocis | Neocis Guidance System (NGS) with Chairside Splint | February 22, 2018 |