Recognized standard
20608 First edition 2018-04
FDA recognition 4-337 · ISO · Dental/ENT
Key facts
| Recognition number | 4-337 |
|---|---|
| Designation | 20608 First edition 2018-04 |
| Title | Dentistry - Powder jet handpieces and powders |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1). ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry… |
At a glance
- 1–9 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: