FDA Product Code
FDA Product Code PLV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4120
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252376 | Yomi S Robotic System | Neocis, Inc. | 2025-10-28 | Traditional | PDF ↗ |
| K251835 | Yomi Robotic System | Neocis, Inc. | 2025-10-10 | Traditional | PDF ↗ |
| K233563 | Navident | Claronav, Inc. | 2024-07-25 | Traditional | PDF ↗ |
| K231018 | Yomi Robotic System | Neocis, Inc. | 2023-08-14 | Traditional | PDF ↗ |
| K210947 | Navident | Claronav, Inc. | 2022-06-27 | Traditional | PDF ↗ |
| K211466 | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | 2022-06-14 | Traditional | PDF ↗ |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | 2022-02-22 | Traditional | PDF ↗ |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021-12-22 | Traditional | PDF ↗ |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | 2021-07-28 | Traditional | PDF ↗ |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | 2020-12-15 | Special | PDF ↗ |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020-12-04 | Traditional | PDF ↗ |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Neocis, Inc. | 2020-10-19 | Traditional | PDF ↗ |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | 2020-07-28 | Traditional | PDF ↗ |
| K200662 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | 2020-05-21 | Special | PDF ↗ |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis, Inc. | 2020-05-08 | Traditional | PDF ↗ |
| K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2020-02-03 | Traditional | PDF ↗ |
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | Neocis, Inc. | 2019-10-02 | Traditional | PDF ↗ |
| K191605 | Neocis Guidance System (NGS) | Neocis, Inc. | 2019-09-11 | Traditional | PDF ↗ |
| K182776 | Neocis Guidance System | Neocis, Inc. | 2018-12-21 | Special | PDF ↗ |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | 2018-02-22 | Traditional | PDF ↗ |
| K161399 | Neocis Guidance System | Neocis, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K161406 | Navident | Claronav, Inc. | 2016-09-08 | Traditional | PDF ↗ |
| K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015-10-08 | Traditional | PDF ↗ |
Product code PLV · Class II · Dental. Data: openFDA.