Recognized standard
Standard No. 87-1995 (R2014)
FDA recognition 4-286 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-286 |
|---|---|
| Designation | Standard No. 87-1995 (R2014) |
| Title | Dental Impression Trays |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | This specification applies to reusable and disposable impression trays used in dentistry for delivering impression materials into the oral cavity for the purpose of making impressions (negative copies) of teeth and oral tissues. It applies to trays made of plastic, aluminum, stainless steel and… |
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: