21 CFR 872.4730 — Needle, Dental
Dental (DE) · Subpart E—Surgical Devices · § 872.4730
Identification
A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs.
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 |
|---|---|---|---|---|
| DZM | Needle, Dental | 1 | 16 | |
| NMW | Needle, Dental, Reprocessed | 1 | 0 | 3rd Party |
