Mesheet

FDA 510(k) K233544 · Dentis Co., Ltd.

Substantially Equivalent

510(k) numberK233544

Submission

Device name
Mesheet
Applicant
Dentis Co., Ltd.
Daegu, KR
Received
November 3, 2023
Decision date
February 22, 2024
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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K260527FACE4D AlignerNXC · Traditional Avinent Implant System S.L.U.07/02/2026SE
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K260722SureSmile Aligner (ASSY500020)NXC · Traditional Dentsply Sirona, Inc.04/15/2026SE
K253282ZSmile SystemNXC · Special Dror Orthodesign , Ltd.02/03/2026SE
K251454Clear Aligner (SCF-3348)NXC · Traditional Beame Medical Technology (Shenzhen) Limited01/07/2026SE
K250739Primeprint Direct AlignerNXC · Traditional Dreve Dentamid GmbH11/07/2025SE
K252931Invisalign® Palatal Expander SystemNXC · Special Align Technology, Inc.10/23/2025SE
K252870Invisalign Specifix Attachment SystemNXC · Special Align Technology, Inc.10/09/2025SE
K251758Serafin®NXC · Traditional Tns Co., Ltd.09/11/2025SE
K252380Invisalign SystemNXC · Special Align Technology, Inc.08/29/2025SE

More from Align Technology, Inc.

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K253493Dentis SQ-SL AXEL FixtureDZE · Traditional 03/04/2026SE
K241065ChecQ (AC100)EKX · Traditional 03/21/2025SE
K233921Luvis Chair (LC700C)KLC · Traditional 09/06/2024SE
K241063s-Clean ScanHealing AbutmentNHA · Traditional 07/25/2024SE
K240511Dentis s-Clean SQ-SL FixtureDZE · Traditional 05/20/2024SE
K230126Dentis s-Clean Regular AbutmentNHA · Traditional 08/04/2023SE
K230307Dentis i-Clean SystemNHA · Traditional 07/11/2023SE
K230246Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional 05/25/2023SE
K230523s-Clean Link Abutment NarrowNHA · Traditional 05/24/2023SE
K230203Dentis I-FIX AbutmentNHA · Traditional 05/03/2023SE

Questions and answers

When was Mesheet cleared by the FDA?

Mesheet (K233544) received a 510(k) decision of Substantially Equivalent on February 22, 2024, 111 days after the submission was received.

What is the product code of K233544?

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