| Device Type ID | 1145 |
| Device Name | Heat Source For Bleaching Teeth |
| Regulation Description | Heat Source For Bleaching Teeth. |
| 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) Exempt |
| CFR Regulation Number | 872.6475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EEG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1145 |
| Device | Heat Source For Bleaching Teeth |
| Product Code | EEG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Heat Source For Bleaching Teeth. |
| CFR Regulation Number | 872.6475 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 21 |
Patient-Device Incompatibility | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Off-Label Use | 1 |
| Total Device Problems | 31 |