NLD · Instrument, Diamond, Dental, Reprocessed
Dental · 21 CFR 872.4535 · Class 1
Overview
| Product Code | NLD |
|---|---|
| Device Name | Instrument, Diamond, Dental, Reprocessed |
| Regulation | 21 CFR 872.4535 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
