PLV · Dental Stereotaxic Instrument
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | PLV |
|---|---|
| Device Name | Dental Stereotaxic Instrument |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
Classification Rationale
Class II.
Cleared Devices (23)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252376 | Yomi S Robotic System | Neocis, Inc. | Oct 28, 2025 | SESE |
| K251835 | Yomi Robotic System | Neocis, Inc. | Oct 10, 2025 | SESE |
| K233563 | Navident | Claronav, Inc. | Jul 25, 2024 | SESE |
| K231018 | Yomi Robotic System | Neocis, Inc. | Aug 14, 2023 | SESE |
| K210947 | Navident | Claronav, Inc. | Jun 27, 2022 | SESE |
| K211466 | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | Jun 14, 2022 | SESE |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | Feb 22, 2022 | SESE |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | Dec 22, 2021 | SESE |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | Jul 28, 2021 | SESE |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | Dec 15, 2020 | SESE |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | Dec 4, 2020 | SESE |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Neocis, Inc. | Oct 19, 2020 | SESE |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | Jul 28, 2020 | SESE |
| K200662 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | May 21, 2020 | SESE |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis, Inc. | May 8, 2020 | SESE |
| K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Feb 3, 2020 | SESE |
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | Neocis, Inc. | Oct 2, 2019 | SESE |
| K191605 | Neocis Guidance System (NGS) | Neocis, Inc. | Sep 11, 2019 | SESE |
| K182776 | Neocis Guidance System | Neocis, Inc. | Dec 21, 2018 | SESE |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | Feb 22, 2018 | SESE |
| K161399 | Neocis Guidance System | Neocis, Inc. | Dec 22, 2016 | SESE |
| K161406 | Navident | Claronav, Inc. | Sep 8, 2016 | SESE |
| K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Oct 8, 2015 | SESE |
Top Applicants
- Neocis, Inc. — 16 clearances
- X-Nav Technologies, LLC — 3 clearances
- Claronav, Inc. — 3 clearances
- Navigate Surgical Technologies, Inc. — 1 clearance
