Mtm(R) Clear Aligner

FDA 510(k) K132145 · Dentsply International, Inc.

Substantially Equivalent

510(k) numberK132145

Submission

Device name
Mtm(R) Clear Aligner
Applicant
Dentsply International, Inc.
York, PA, US
Received
July 11, 2013
Decision date
October 11, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NXC – Aligner, Sequential
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

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Questions and answers

When was Mtm(R) Clear Aligner cleared by the FDA?

Mtm(R) Clear Aligner (K132145) received a 510(k) decision of Substantially Equivalent on October 11, 2013, 92 days after the submission was received.

What is the product code of K132145?

The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.