Recognized standard
/TS 16506 First edition 2018-03
FDA recognition 4-324 · ISO · Dental/ENT
Key facts
| Recognition number | 4-324 |
|---|---|
| Designation | /TS 16506 First edition 2018-03 |
| Title | Dentistry - Polymer-based luting materials containing adhesive components |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies test methods and information of bond strength to dentine and physical and chemical performances of dental polymer-based luting materials containing adhesive components. The materials are supplied in a form suitable for mechanical mixing or hand-mixing, including using… |
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: