← Product Code [KKO](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO) · K902974

# COOLING TEETHERS (K902974)

_Realgrow Intl. Corp. · KKO · Apr 3, 1991 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K902974

## Device Facts

- **Applicant:** Realgrow Intl. Corp.
- **Product Code:** [KKO](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO.md)
- **Decision Date:** Apr 3, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5550
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K902974](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K902974)

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