Dental Navigation System
Dental · 21 CFR 872.4120
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
Recent MDR events
9 adverse event reports on file
- X-GUIDE SURGICAL NAVIGATION SYSTEMNov 13, 2024MalfunctionX-nav Technologies, Llc3011764595-2024-00001
- YOMI GUIDED DENTAL IMPLANT ROBOTFeb 23, 2024InjuryNeocis IncMW5151999
- YOMI ROBOTIC SYSTEMNov 13, 2023InjuryNeocis, Inc.3012787974-2023-80079
- YOMI ROBOTIC SYSTEMNov 6, 2023InjuryNeocis, Inc.3012787974-2023-80078
- YOMI ROBOTIC SYSTEMNov 5, 2023InjuryNeocis, Inc.3012787974-2023-80077
- YOMI ROBOTIC ASSISTANCE DEVICEFeb 28, 2023InjuryNeocis Inc.MW5115339
- YOMI ROBOTIC ASSISTANTFeb 28, 2023InjuryNeocis Inc.MW5115340
- YOMI ROBOTIC ASSISTANTFeb 28, 2023InjuryNeocis Inc.MW5115342
- YOMI ROBOTIC ASSISTANT FOR DENTAL IMPLANT PLACEMENTFeb 28, 2023InjuryNeocis Inc.MW5115344
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- X-NAV Technologies, LLCOpen, ClassifiedMar 29, 2024
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Z-1392-2024 · View FDA record ↗ - X-NAV Technologies, LLCOpen, ClassifiedMar 29, 2024
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Z-1393-2024 · View FDA record ↗ - X-NAV Technologies, LLCOpen, ClassifiedNov 10, 2022
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration.
Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.
Z-0222-2023 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
4 clearances for this product code