Product code PLV— Dental
Navident
- Classification name
- Dental Stereotaxic Instrument
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Total cleared
- 23
- First cleared
- Most recent
FDA classification definition
“To facilitate dental implant placement in patients that are partially endentulous or edentulous.”
Market context for product code PLV
FDA has cleared devices under product code PLV between 2015 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2016
- 2015
Top applicants under product code PLV
Recent clearances under product code PLV
- K252376 — Yomi S Robotic System
- K251835 — Yomi Robotic System
- K233563 — Navident
- K231018 — Yomi Robotic System
- K210947 — Navident
- K211466 — Yomi Robotic System with YomiPlan Go
- K213392 — INLIANT Surgical Navigation System
- K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1
- K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array
- K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS)
- K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0
- K202100 — Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
- K200805 — Neocis Guidance System (NGS) with Patient Splints
- K200662 — X-Guide® Surgical Navigation System
- K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
- K192579 — X-Guide Surgical Navigation System
- K191363 — Neocis Planning Software Application (NPSA) for 3rd Party PCs
- K191605 — Neocis Guidance System (NGS)
- K182776 — Neocis Guidance System
- K173402 — Neocis Guidance System (NGS) with Chairside Splint
- K161399 — Neocis Guidance System
- K161406 — Navident
- K150222 — X-Guide Surgical Navigation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.