Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5550](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5550) → MEF — Ring, Teething, Non-Fluid Filled

# MEF · Ring, Teething, Non-Fluid Filled

_Dental · 21 CFR 872.5550 · Class 1_

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

## Overview

- **Product Code:** MEF
- **Device Name:** Ring, Teething, Non-Fluid Filled
- **Regulation:** [21 CFR 872.5550](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5550)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/MEF/K034017.md) | JEJE TEETHER | Vibe 2000 | Oct 18, 2004 | SESE |

## Top Applicants

- Vibe 2000 — 1 clearance

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

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