Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120) → PLV — Dental Stereotaxic Instrument # PLV · Dental Stereotaxic Instrument _Dental · 21 CFR 872.4120 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV ## Overview - **Product Code:** PLV - **Device Name:** Dental Stereotaxic Instrument - **Regulation:** [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) ## 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. ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252376](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K252376.md) | Yomi S Robotic System | Neocis, Inc. | Oct 28, 2025 | SESE | | [K251835](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K251835.md) | Yomi Robotic System | Neocis, Inc. | Oct 10, 2025 | SESE | | [K233563](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K233563.md) | Navident | Claronav, Inc. | Jul 25, 2024 | SESE | | [K231018](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K231018.md) | Yomi Robotic System | Neocis, Inc. | Aug 14, 2023 | SESE | | [K210947](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K210947.md) | Navident | Claronav, Inc. | Jun 27, 2022 | SESE | | [K211466](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K211466.md) | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | Jun 14, 2022 | SESE | | [K213392](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K213392.md) | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | Feb 22, 2022 | SESE | | [K210711](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K210711.md) | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | Dec 22, 2021 | SESE | | [K211129](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K211129.md) | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | Jul 28, 2021 | SESE | | [K203401](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K203401.md) | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | Dec 15, 2020 | SESE | | [K202264](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K202264.md) | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | Dec 4, 2020 | SESE | | [K202100](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K202100.md) | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Neocis, Inc. | Oct 19, 2020 | SESE | | [K200805](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K200805.md) | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | Jul 28, 2020 | SESE | | [K200662](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K200662.md) | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | May 21, 2020 | SESE | | [K200348](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K200348.md) | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis, Inc. | May 8, 2020 | SESE | | [K192579](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K192579.md) | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Feb 3, 2020 | SESE | | [K191363](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K191363.md) | Neocis Planning Software Application (NPSA) for 3rd Party PCs | Neocis, Inc. | Oct 2, 2019 | SESE | | [K191605](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K191605.md) | Neocis Guidance System (NGS) | Neocis, Inc. | Sep 11, 2019 | SESE | | [K182776](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K182776.md) | Neocis Guidance System | Neocis, Inc. | Dec 21, 2018 | SESE | | [K173402](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV/K173402.md) | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | Feb 22, 2018 | SESE | ## Top Applicants - Neocis, Inc. — 16 clearances - Claronav, Inc. — 3 clearances - X-Nav Technologies, LLC — 3 clearances - Navigate Surgical Technologies, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/PLV) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com