Recognized standard
1797 Third Edition 2017-05 Standard No. 179-2020
FDA recognition 4-281 · ISO · Dental/ENT
Key facts
| Recognition number | 4-281 |
|---|---|
| Designation | 1797 Third Edition 2017-05 Standard No. 179-2020 |
| Title | Dentistry - Shanks for rotary and oscillating instruments Shanks for Rotary and Oscillating Instruments |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | ISO 1797:2017 specifies the requirements for dimensions and material properties of shanks used in dentistry for rotary or oscillating instruments. It describes the measurement methods for the verification of the requirements. ISO 1797:2017 is not applicable to tips fixed to the handpiece with a… |
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: