Product code PLV
- Device name
- Dental Stereotaxic Instrument
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4120
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To facilitate dental implant placement in patients that are partially endentulous or edentulous.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252376 | Yomi S Robotic System | Neocis, Inc. | 2025-10-28 |
| K251835 | Yomi Robotic System | Neocis, Inc. | 2025-10-10 |
| K233563 | Navident | Claronav, Inc. | 2024-07-25 |
| K231018 | Yomi Robotic System | Neocis, Inc. | 2023-08-14 |
| K210947 | Navident | Claronav, Inc. | 2022-06-27 |
| K211466 | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | 2022-06-14 |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | 2022-02-22 |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021-12-22 |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | 2021-07-28 |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | 2020-12-15 |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020-12-04 |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Neocis, Inc. | 2020-10-19 |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | 2020-07-28 |
| K200662 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | 2020-05-21 |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis, Inc. | 2020-05-08 |
| K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2020-02-03 |
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | Neocis, Inc. | 2019-10-02 |
| K191605 | Neocis Guidance System (NGS) | Neocis, Inc. | 2019-09-11 |
| K182776 | Neocis Guidance System | Neocis, Inc. | 2018-12-21 |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | 2018-02-22 |
| K161399 | Neocis Guidance System | Neocis, Inc. | 2016-12-22 |
| K161406 | Navident | Claronav, Inc. | 2016-09-08 |
| K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015-10-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810004900851 | O Rings for Yomi S TEE Screw Bag of 25 | NEOCIS INC | 2026-06-03 |
| 00810004900813 | Yomi S Fiducial Array Screw | NEOCIS INC | 2025-12-01 |
| 00810004900646 | Yomi S Extra Oral Fiducial Array LRUL | NEOCIS INC | 2025-12-01 |
| 00810004900639 | Yomi S Extra Oral Fiducial Array LLUR | NEOCIS INC | 2025-12-01 |
| 00810004900653 | Yomi S Intra Oral Fiducial Array Small | NEOCIS INC | 2025-12-01 |
| 00810004900660 | Yomi S Intra Oral Fiducial Array Medium | NEOCIS INC | 2025-12-01 |
| 00810004900677 | Yomi S Intra Oral Fiducial Array Large | NEOCIS INC | 2025-12-01 |
| 00810004900684 | Yomi S YomiLink Teeth Posterior LLUR | NEOCIS INC | 2025-12-01 |
| 00810004900837 | Yomi S Robotic System | NEOCIS INC | 2025-12-01 |
| 00810004900691 | Yomi S YomiLink Teeth Posterior LRUL | NEOCIS INC | 2025-12-01 |
| 00810004900707 | Yomi S YomiLink Arch LLUR | NEOCIS INC | 2025-12-01 |
| 00810004900714 | Yomi S YomiLink Arch LRUL | NEOCIS INC | 2025-12-01 |
| 00810004900721 | Yomi S YomiLink Teeth Anterior LLUR | NEOCIS INC | 2025-12-01 |
| 00810004900738 | Yomi S YomiLink Teeth Anterior LRUL | NEOCIS INC | 2025-12-01 |
| 00810004900745 | Yomi S YomiLink Bone Lower LL | NEOCIS INC | 2025-12-01 |
| 00810004900752 | Yomi S YomiLink Bone Lower LR | NEOCIS INC | 2025-12-01 |
| 00810004900769 | Yomi S YomiLink Bone Upper UL | NEOCIS INC | 2025-12-01 |
| 00817421022753 | X-Guide | XNAV TECHNOLOGIES LLC | 2024-09-05 |
| 00817421022609 | X-Guide | XNAV TECHNOLOGIES LLC | 2023-01-30 |
| 00817421022593 | X-Guide | XNAV TECHNOLOGIES LLC | 2023-01-30 |
| 00817421022500 | X-Guide | XNAV TECHNOLOGIES LLC | 2023-01-30 |
| 00817421022418 | X-Guide | XNAV TECHNOLOGIES LLC | 2023-01-30 |
| 00810004900448 | Neocis Guidance System | NEOCIS INC | 2020-10-19 |
| 00810004900431 | Neocis Guidance System | NEOCIS INC | 2020-10-19 |
| 00810004900424 | Neocis Guidance System | NEOCIS INC | 2020-10-19 |
| 00810004900417 | Neocis Guidance System | NEOCIS INC | 2020-10-19 |
| 00810004900387 | Neocis Guidance System | NEOCIS INC | 2020-07-28 |
| 00810004900370 | Neocis Guidance System | NEOCIS INC | 2020-07-28 |
| 00810004900363 | Neocis Guidance System | NEOCIS INC | 2020-07-28 |
| 00810004900356 | Neocis Guidance System | NEOCIS INC | 2020-07-28 |