PLV

Dental Stereotaxic Instrument

Product code
PLV
Device name
Dental Stereotaxic Instrument
Device class
Class 2
21 CFR
21 CFR 872.4120
Medical specialty
Dental
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
23 (all years; only the last 3 years are listed here)

FDA classification definition

To facilitate dental implant placement in patients that are partially endentulous or edentulous.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-10-28.

NumberDecision dateApplicantDevice nameSummary
K2523762025-10-28Neocis, Inc.Yomi S Robotic SystemPDF
K2518352025-10-10Neocis, Inc.Yomi Robotic SystemPDF
K2335632024-07-25Claronav, Inc.NavidentFDA

2 summaries are archived here for direct download.

Official FDA classification page: PLV
Classification and pathway per current FDA publications. Data from openFDA (CC0).