ELJ · Teeth, Artificial, Posterior With Metal Insert
Dental · 21 CFR 872.3900 · Class 1
Overview
| Product Code | ELJ |
|---|---|
| Device Name | Teeth, Artificial, Posterior With Metal Insert |
| Regulation | 21 CFR 872.3900 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A posterior artificial tooth with a metal insert is a porcelain device with an insert made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to replace a natural tooth. The device is attached to surrounding teeth by a bridge and is intended to provide both an improvement in appearance and functional occlusion (bite).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
