MTM Clear Aligner

FDA 510(k) K163155 · Dentsply Sirona

Substantially Equivalent

510(k) numberK163155

Submission

Device name
MTM Clear Aligner
Applicant
Dentsply Sirona
York, PA, US
Received
November 10, 2016
Decision date
February 3, 2017
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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K260722SureSmile Aligner (ASSY500020)NXC · Traditional 04/15/2026SE
K253565SureSmile SoftwarePNN · Traditional 03/04/2026SE
K251614Stainless Steel Surgical KitsKCT · Traditional 02/06/2026SE
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Questions and answers

When was MTM Clear Aligner cleared by the FDA?

MTM Clear Aligner (K163155) received a 510(k) decision of Substantially Equivalent on February 3, 2017, 85 days after the submission was received.

What is the product code of K163155?

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