Recognized standard
Standard No. 85-2004 (R2009)
FDA recognition 4-279 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-279 |
|---|---|
| Designation | Standard No. 85-2004 (R2009) |
| Title | Part 1: Disposable Prophy Angles |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard covers disposable prophy angles suitable for a dental hygienist or dentist to use in conjunction with a doriot style handpiece during the final stages of a dental cleaning, also known as a polish. |
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: