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Dental Stereotaxic Instrument
FDA product code PLV · Class 2 · Dental
207
Registered devices
85
Adverse events
6
Recalls
23
510(k) clearances
Devices with this code
Neocis Guidance System — NEOCIS INCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCNavident Procedure Kit — Claronav IncYomiLink Arch (LRUL) — NEOCIS INCX-Guide — XNAV TECHNOLOGIES LLCYomiLink Teeth Posterior (LRUL) — NEOCIS INCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCNeocis Guidance System — NEOCIS INCYomi S YomiLink-TEE Screw — NEOCIS INCYomi S Intra Oral Fiducial Array Large — NEOCIS INCX-Guide — XNAV TECHNOLOGIES LLCNavident — Claronav IncYomi S YomiLink Arch LLUR — NEOCIS INCX-GUIDE — XNAV TECHNOLOGIES LLCNeocis Guidance System — NEOCIS INCYomi S Extra Oral Fiducial Array LLUR — NEOCIS INCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCX-GUIDE — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-30 | Neocis, Inc. | The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. |
| 2020-05-14 | Neocis Inc. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| 2020-05-14 | Neocis Inc. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| 2020-05-14 | Neocis Inc. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| 2019-10-04 | Neocis Inc. | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. |
| 2016-02-23 | X-NAV Technologies, LLC | The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn int |
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