| Device Type ID | 1243 |
| Device Name | Teeth, Porcelain |
| Regulation Description | Porcelain Tooth. |
| 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 | 872.3920 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ELL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1243 |
| Device | Teeth, Porcelain |
| Product Code | ELL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Porcelain Tooth. |
| CFR Regulation Number | 872.3920 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NOBEL BIOCARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NOBEL BIOCARE AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |