| Device Type ID | 1429 |
| Device Name | Cement, Ear, Nose And Throat |
| Regulation Description | Dental Cement. |
| Regulation Medical Specialty | Dental |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.3275 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NEA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1429 |
| Device | Cement, Ear, Nose And Throat |
| Product Code | NEA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Dental Cement. |
| CFR Regulation Number | 872.3275 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OTOTRONIX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Chemical Problem | 6 |
Physical Property Issue | 3 |
Failure To Adhere Or Bond | 3 |
Precipitate In Device Or Device Ingredient | 1 |
Improper Chemical Reaction | 1 |
| Total Device Problems | 14 |