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Baby Snoopy Water Filled Teether, Model 95367

by Delta Enterprise Corporation 510(k)

Active United States

510(k) K052513

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052513 Date28 Jun 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KKO
Device Class
Class II
Regulation
21 CFR Part 872.5550
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Baby Snoopy Water-Filled Teether, Model 95367, is a Ring, Teething, Fluid-Filled device designed to alleviate infant teething discomfort. It is a handheld, water-filled teether shaped as a character, intended for oral use by infants to soothe gums through a cooling effect.

This device is supplied as a single-use item, requiring cleaning with warm soapy water, rinsing, and refrigeration before use. It is classified under FDA regulation 872.5550 and falls under Product Code KKO, with a regulatory class of I1. The device is intended for home use and must be handled in accordance with standard infant oral care practices.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • How should I prepare the Baby Snoopy Water-Filled Teether before giving it to my infant for use?

    Before use, the Baby Snoopy Water-Filled Teether must be cleaned with warm soapy water, thoroughly rinsed, and then refrigerated. This process helps maintain hygiene and provides a cooling effect to soothe teething discomfort. Always follow standard infant oral care practices when handling the device.

  • Is the Baby Snoopy Water-Filled Teether intended for single-use or can it be reused?

    The Baby Snoopy Water-Filled Teether is designed for repeated use with proper cleaning and refrigeration between sessions. However, it is not a sterile device, so cleaning with warm soapy water and rinsing is required before each use to ensure safety and hygiene. The manufacturer recommends refrigeration after cleaning to enhance its soothing effect.

  • What sizes or variations of the Baby Snoopy Water-Filled Teether are available?

    The Baby Snoopy Water-Filled Teether is supplied as a single model (Model 95367) and is shaped as a character for easy handling by infants. While the device itself is uniform in design, it is available in multiple registration numbers (e.g., 3025436467, 3002857192, etc.), which likely correspond to different distribution lots or packaging configurations rather than physical size variations. Always verify the packaging for the correct model number.

  • What regulatory pathway was followed for the Baby Snoopy Water-Filled Teether, and who can I contact for further details?

    The Baby Snoopy Water-Filled Teether was cleared through the FDA’s 510(k) Traditional pathway, classified under Product Code KKO (Ring, Teething, Fluid-Filled) and Regulation 872.5550. It was reviewed by the Dental (DE) Advisory Committee and determined to be Substantially Equivalent (SESE) to a predicate device. For further inquiries, you may contact Maria E. Celis at Delta Enterprise Corporation, located at 17 State St., 19th Floor, New York, NY 10004.