Definition: The Device Is Intended To Enable Access To Secure Patient Identification And Device Information When Used With Complete Dentures, Partial Dentures, And Other Removable Oral Appliances.
| Device Type ID | 2788 |
| Device Name | Rfid Chip For Dental Appliance |
| Physical State | Solid State RFID Transponder Embedded In A Resin |
| Technical Method | Uses RFID Transponder And NFC To Transmit Information To A Mobile Device. |
| Target Area | Embedded In Removable Oral Appliances |
| Regulation Description | Implantable Radiofrequency Transponder System For Patient Identification And Health Information. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PYQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2788 |
| Device | Rfid Chip For Dental Appliance |
| Product Code | PYQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Radiofrequency Transponder System For Patient Identification And Health Information. |
| CFR Regulation Number | 880.6300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CMP INDUSTRIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |