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Mam Twister

by Mam International AG

510(k) K092781

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 NumberK092781 Date23 Jun 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  • Withdrawn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, 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 Mam Twister is a Ring, Teething, Fluid-Filled, classified under FDA regulation 872.5550. This device is designed as a dental teething ring intended to provide relief for infants experiencing teething discomfort by offering a textured, fluid-filled surface for chewing.

Supplied as a single-use item, the Mam Twister is intended for home use and does not require sterilisation. It is manufactured under FDA 510(k) clearance (K092781) and falls under Class II medical devices. Available in multiple sizes (as indicated by the listed FEI numbers), it is regulated for dental applications and must comply with FDA standards for safety and performance.

Other devices from Mam International AG

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