Cleared Traditional

K092781 - MAM TWISTER

K092781 is an FDA 510(k) clearance for MAM TWISTER, manufactured by Mam International AG. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K092781 · Mam International AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
286d
Days
Class 2
Risk

K092781 is an FDA 510(k) clearance for the MAM TWISTER. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Mam International AG (White Plains, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 286 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5550 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092781

510(k) Number K092781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2009
Decision Date June 23, 2010
Days to Decision 286 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 128d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKO Device Classification - Class 2, Special Controls

Product Code KKO Ring, Teething, Fluid-filled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KKO Ring, Teething, Fluid-filled

All 26
Devices cleared under the same product code (KKO) and FDA review panel - the closest regulatory comparables to K092781.
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
K110615 · Bebe Toys Manufactory , Ltd. · Dec 2011
FLUID FILLED TEETHER - GEL
K092025 · Kids II · Jan 2011
MAM COOLER
K093266 · Mam International AG · Jul 2010
GEL FILLED GUM SOOTHER
K092494 · Luv N' Care, Ltd. · Mar 2010
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
K093370 · Fu Hong Industries , Ltd. · Jan 2010
FLUID-FILLED TEETHER
K092910 · Qualiman Industrial Co., Ltd. · Dec 2009
K092781 · MAM TWISTER
Download PDF FDA Summary Mam International AG