Definition: To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous.
| Device Type ID | 1383 |
| Device Name | Dental Stereotaxic Instrument |
| Physical State | A Cart Mounted System That Physically Attaches To The Patient As Well As The Surgical Instrument In Order To Detect The Location Of The Device In Physical Space. |
| Technical Method | The Device Uses Stereo Cameras To Detect Tracking Devices Placed On Both The Surgical Instrument As Well As On The Patient. The Tracked Image Is Then Placed On A Screen With Predetermined Anatomical Landmarks To Assist The Clinician With The Surgical |
| Target Area | Intraoral Surgical Procedures In The Mouth. |
| Regulation Description | Bone Cutting Instrument And Accessories. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.4120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1383 |
| Device | Dental Stereotaxic Instrument |
| Product Code | PLV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Cutting Instrument And Accessories. |
| CFR Regulation Number | 872.4120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CLARONAV INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOCIS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-NAV TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | X-NAV Technologies, LLC | II | Apr-14-2016 |