Recognized standard
4049 Fifth edition 2019-05 Standard No. 27-2022
FDA recognition 4-298 · ISO · Dental/ENT
Key facts
| Recognition number | 4-298 |
|---|---|
| Designation | 4049 Fifth edition 2019-05 Standard No. 27-2022 |
| Title | Dentistry - Polymer-based restorative materials Polymer-based Restorative Materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for… |
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: