21 CFR 872.4535 — Instrument, Diamond, Dental
Dental (DE) · Subpart E—Surgical Devices · § 872.4535
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DZP | Instrument, Diamond, Dental | 1 | 21 | |
| NLD | Instrument, Diamond, Dental, Reprocessed | 1 | 0 | 3rd Party |
