21 CFR 872.4130 — Drill, Dental, Intraoral
Dental (DE) · Subpart E—Surgical Devices · § 872.4130
Identification
An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | 1 | 13 |