3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

Q: What is the product code of K211190?

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

FDA 510(k) K211190 · 3M Company, Unitek Orthodontic Products

Substantially Equivalent

510(k) numberK211190

Submission

Device name: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Applicant: 3M Company, Unitek Orthodontic Products
Saint Paul, MN, US
Received: April 21, 2021
Decision date: April 23, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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.

Other 510(k)s with product code NXC

510(k)	Device	Applicant	Decision
K260527	FACE4D AlignerNXC · Traditional	Avinent Implant System S.L.U.	07/02/2026SE
K260788	Smylio AlignersNXC · Traditional	Smylio, Inc.	05/08/2026SE
K260722	SureSmile Aligner (ASSY500020)NXC · Traditional	Dentsply Sirona, Inc.	04/15/2026SE
K253282	ZSmile SystemNXC · Special	Dror Orthodesign , Ltd.	02/03/2026SE
K251454	Clear Aligner (SCF-3348)NXC · Traditional	Beame Medical Technology (Shenzhen) Limited	01/07/2026SE
K250739	Primeprint Direct AlignerNXC · Traditional	Dreve Dentamid GmbH	11/07/2025SE
K252931	Invisalign® Palatal Expander SystemNXC · Special	Align Technology, Inc.	10/23/2025SE
K252870	Invisalign Specifix Attachment SystemNXC · Special	Align Technology, Inc.	10/09/2025SE
K251758	Serafin®NXC · Traditional	Tns Co., Ltd.	09/11/2025SE
K252380	Invisalign SystemNXC · Special	Align Technology, Inc.	08/29/2025SE

More from Align Technology, Inc.

510(k)	Device	Decision
K233257	3M ClarityAligners with Quick AttachmentsNXC · Traditional	09/29/2023SE
K231464	3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)NXC · Traditional	05/22/2023SE

Questions and answers

When was 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) cleared by the FDA?

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (K211190) received a 510(k) decision of Substantially Equivalent on April 23, 2021, 2 days after the submission was received.

What is the product code of K211190?

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