21 CFR 872.4200 — Controller, Foot, Handpiece And Cord
Dental (DE) · Subpart E—Surgical Devices · § 872.4200
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Classification Rationale
Class I.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | 1 | 61 | 3rd Party |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 1 | 25 | 3rd Party |
| EFB | Handpiece, Air-Powered, Dental | 1 | 261 | 3rd Party |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 73 | 3rd Party |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 89 | 3rd Party |
| EKY | Handpiece, Water-Powered | 1 | 2 | 3rd Party |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | 1 | 5 | 3rd Party |
