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Cooling Teethers

by Realgrow Intl. Corp.

510(k) K902974

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902974 Date3 Apr 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 1 Oct 2026

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

The Cooling Teethers are a class II medical device classified as a Ring, Teething, Fluid-Filled, designed to provide relief for infants experiencing teething discomfort. These devices are filled with a cooling fluid, which helps soothe gums when chilled and applied to the affected area. Their primary function is to offer temporary relief from the pain and irritation associated with teething.

Cooling Teethers are intended for single-use in a home or pediatric care setting and are regulated under FDA 510(k) clearance (K902974) with a decision of Substantially Equivalent (SESE). They fall under the product code KKO and regulation number 872.5550, adhering to dental medical specialty standards. The devices are not reusable and require proper storage to maintain sterility before use.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the primary purpose of Cooling Teethers?

    Cooling Teethers are designed to relieve teething discomfort in infants by applying a chilled, fluid-filled ring to the gums. The cooling effect helps numb the area, providing temporary relief from the pain and irritation caused by emerging teeth. They are specifically intended for use in home or pediatric care settings.

  • Are Cooling Teethers reusable or single-use?

    Cooling Teethers are intended for single-use only. This design ensures sterility and hygiene, as reuse could compromise the device’s integrity and potentially introduce contamination, which is particularly important for infant use.

  • How should Cooling Teethers be stored to maintain sterility?

    Cooling Teethers must be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve their sterility before use. Proper storage ensures the fluid remains intact and the device remains uncontaminated, maintaining its effectiveness for soothing teething discomfort.

  • What regulatory approval does Cooling Teethers have?

    Cooling Teethers are FDA-cleared under the 510(k) pathway with the clearance number K902974. They are classified as a Class II medical device under the product code KKO and regulation number 872.5550, adhering to dental medical specialty standards. The decision was determined to be Substantially Equivalent (SESE).

  • What sizes or models of Cooling Teethers are available?

    Cooling Teethers come in multiple registration numbers, indicating various models or variants (e.g., 3025436467, 3002857192, etc.). These likely correspond to different sizes or slight design variations to accommodate varying infant gum sizes and preferences. For precise sizing details, refer to the manufacturer’s packaging or documentation.