21 CFR 872.5550 — Ring, Teething, Fluid-Filled
Dental (DE) · Subpart F—Therapeutic Devices · § 872.5550
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KKO | Ring, Teething, Fluid-Filled | 2 | 27 | |
| MEF | Ring, Teething, Non-Fluid Filled | 1 | 1 |
Special Controls
KKO — Ring, Teething, Fluid-Filled
*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.
eCFR
MEF — Ring, Teething, Non-Fluid Filled
*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.
eCFR
