Recognized standard
28319 Second edition 2018-04 Standard No. 84-2020
FDA recognition 4-247 · ISO · Dental/ENT
Key facts
| Recognition number | 4-247 |
|---|---|
| Designation | 28319 Second edition 2018-04 Standard No. 84-2020 |
| Title | Dentistry - Laser welding and filler materials Laser Welding and Filler Materials in Dentistry |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances. For filler materials used in laser welding, this document also specifies the information given in the… |
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: