3M Clarity Aligners

Q: What is the product code of K183159?

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

FDA 510(k) K183159 · 3M Company

Substantially Equivalent

510(k) numberK183159

Submission

Device name: 3M Clarity Aligners
Applicant: 3M Company
Saint Paul, MN, US
Received: November 15, 2018
Decision date: November 26, 2018
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
K243501	3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional	01/28/2025SE
K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional	11/25/2024SE
K241959	3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional	10/18/2024SE
K241710	3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional	09/12/2024SE
K241542	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special	06/27/2024SE
K240717	3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special	06/27/2024SE
K233814	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional	03/15/2024SE
K222578	3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional	05/18/2023SE
K222508	3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional	11/01/2022SE
K222152	3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional	09/23/2022SE

Questions and answers

When was 3M Clarity Aligners cleared by the FDA?

3M Clarity Aligners (K183159) received a 510(k) decision of Substantially Equivalent on November 26, 2018, 11 days after the submission was received.

What is the product code of K183159?

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