Recognized standard
10139-2 Third edition 2016-06-15 Standard No. 160-2020
FDA recognition 4-258 · ISO · Dental/ENT
Key facts
| Recognition number | 4-258 |
|---|---|
| Designation | 10139-2 Third edition 2016-06-15 Standard No. 160-2020 |
| Title | Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 10139 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses. |
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: