21 CFR 872.6070 — Activator, Ultraviolet, For Polymerization
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6070
Identification
An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 213 | 3rd Party |
| QNF | Laser Activator For Polymerization | 2 | 2 |