Recognized standard
Standard No. 99-2001 (R2013)
FDA recognition 4-254 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-254 |
|---|---|
| Designation | Standard No. 99-2001 (R2013) |
| Title | Athletic Mouth Protectors and Materials |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This specification is for thermoplastic or thermosetting polymeric materials, with or without a polymeric shell, that are capable of being formed into an athletic mouth protector, either on a model of the teeth or in the mouth directly on the teeth. It lists the types and classes of mouth protectors… |
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: