Recognized standard
10139-1 Third edition 2018-03 Standard No. 75-2020
FDA recognition 4-242 · ISO · Dental/ENT
Key facts
| Recognition number | 4-242 |
|---|---|
| Designation | 10139-1 Third edition 2018-03 Standard No. 75-2020 |
| Title | Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials |
| 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 for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis. |
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: