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Mam Cooler

by Mam International AG

510(k) K093266

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 NumberK093266 Date27 Jul 2010ClearedStatusActive

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  • Withdrawn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, 6 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 Mam Cooler is a ring-shaped, fluid-filled teething device intended for dental use. It is designed to soothe infants during teething by providing a cool, chewable surface.

The device is supplied as a single-use or reusable product, depending on the specific configuration, and is intended for use in home or clinical settings. It has received FDA 510(k) clearance under product code KKO and regulation number 872.5550, with a decision date of July 27, 2010.

Other devices from Mam International AG

  • Mam Twister

    Class II