Invisalign System

Q: When was Invisalign System cleared by the FDA?

Invisalign System (K081960) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 161 days after the submission was received.

Q: What is the product code of K081960?

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

FDA 510(k) K081960 · Align Technology

Substantially Equivalent

510(k) numberK081960

Submission

Device name: Invisalign System
Applicant: Align Technology
Santa Clara, CA, US
Received: July 9, 2008
Decision date: December 17, 2008
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.

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
K261847	iTero Lumina ProNTK · Special	07/02/2026SE
K252931	Invisalign® Palatal Expander SystemNXC · Special	10/23/2025SE
K252870	Invisalign Specifix Attachment SystemNXC · Special	10/09/2025SE
K252380	Invisalign SystemNXC · Special	08/29/2025SE
K240573	iTero Lumina ProNTK · Traditional	08/16/2024SE
K241412	Invisalign SystemNXC · Special	06/18/2024SE
K232887	Invisalign Palatal Expander SystemNXC · Traditional	12/15/2023SE
K232233	Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC · Traditional	09/26/2023SE
K222894	Invisalign System, Pre-Formed Attachment SystemNXC · Traditional	12/22/2022SE
K220287	Invisalign SystemNXC · Special	04/07/2022SE

Questions and answers

When was Invisalign System cleared by the FDA?

Invisalign System (K081960) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 161 days after the submission was received.

What is the product code of K081960?

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