Recognized standard
10650 Second edition 2018-08 Standard No. 48-2020
FDA recognition 4-252 · ISO · Dental/ENT
Key facts
| Recognition number | 4-252 |
|---|---|
| Designation | 10650 Second edition 2018-08 Standard No. 48-2020 |
| Title | Dentistry - Powered polymerization activators Curing Lights (Powered Polymerization Activators) |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED)… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: