FDA product code PLV: Dental Stereotaxic Instrument
PLV is the FDA product code for dental stereotaxic instrument. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 23 510(k) submissions under PLV, 7 in the last five years, from 4 different applicants. The average 510(k) review took 156 days (median 116); 182 days on average over the last three years. FDA has posted 6 recalls for PLV devices.
Definition
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Classification
| Field | Value |
|---|---|
| Device name | Dental Stereotaxic Instrument |
| Device class | Class II |
| Regulation | 21 CFR 872.4120 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for PLV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 98 |
| 2019 | 2 | 110 |
| 2020 | 7 | 91 |
| 2021 | 2 | 195 |
| 2022 | 3 | 328 |
| 2023 | 1 | 126 |
| 2024 | 1 | 262 |
| 2025 | 2 | 103 |
Compare with all 510(k) review times · Search every PLV clearance
Top PLV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neocis, Inc. | 16 | 2025-10-28 |
| Claronav, Inc. | 3 | 2024-07-25 |
| X-Nav Technologies, LLC | 3 | 2020-05-21 |
| Navigate Surgical Technologies, Inc. | 1 | 2022-02-22 |
Most recent PLV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252376 | Neocis, Inc. | Yomi S Robotic System | 2025-10-28 | 90 |
| K251835 | Neocis, Inc. | Yomi Robotic System | 2025-10-10 | 116 |
| K233563 | Claronav, Inc. | Navident | 2024-07-25 | 262 |
| K231018 | Neocis, Inc. | Yomi Robotic System | 2023-08-14 | 126 |
| K210947 | Claronav, Inc. | Navident | 2022-06-27 | 454 |
Recalls for PLV devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-10-30.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 4 |
Frequently asked questions
What is FDA product code PLV?
PLV is the FDA product code for dental stereotaxic instrument. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is PLV?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLV?
Across 23 cleared submissions the average was 156 days from receipt to decision (median 116).
Which companies have the most PLV clearances?
Neocis, Inc. (16); Claronav, Inc. (3); X-Nav Technologies, LLC (3); Navigate Surgical Technologies, Inc. (1).
Have PLV devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2020-10-30.
Next steps
- Run an FDA pathway report with predicate devices for product code PLV
- Run a recall and safety report across every PLV manufacturer
- Watch product code PLV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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