MEF · Ring, Teething, Non-Fluid Filled
Dental · 21 CFR 872.5550 · Class 1
Overview
| Product Code | MEF |
|---|---|
| Device Name | Ring, Teething, Non-Fluid Filled |
| Regulation | 21 CFR 872.5550 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.
Classification Rationale
Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Special Controls
*Classification.* Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K034017 | JEJE TEETHER | Vibe 2000 | Oct 18, 2004 | SESE |
Top Applicants
- Vibe 2000 — 1 clearance
