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Dental Stereotaxic Instrument

FDA product code PLV · Class 2 · Dental

208
Registered devices
85
Adverse events
6
Recalls
23
510(k) clearances

Devices with this code

X-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCNeocis Guidance System — NEOCIS INCX-GUIDE — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCNeocis Guidance System — NEOCIS INCX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCNeocis Guidance System — NEOCIS INCNavident — Claronav IncX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLCNavident — Claronav IncYLB-IOFA- Large — NEOCIS INCYomiLink Bone (UR) — NEOCIS INCX-GUIDE — XNAV TECHNOLOGIES LLCYomi S YomiLink Teeth Anterior LLUR — NEOCIS INCNeocis Guidance System — NEOCIS INCNeocis Guidance System — NEOCIS INCYomiLink Bone (LL) — NEOCIS INCNavident — Claronav IncX-Guide — XNAV TECHNOLOGIES LLCX-Guide — XNAV TECHNOLOGIES LLC

Recent recalls

DateFirmReason
2020-10-30Neocis, Inc.The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
2020-05-14Neocis Inc.The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
2020-05-14Neocis Inc.The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
2020-05-14Neocis Inc.The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
2019-10-04Neocis Inc.The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
2016-02-23X-NAV Technologies, LLCThe 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.