Invisalign System
FDA 510(k) K220287 · Align Technology, Inc.
510(k) numberK220287
Submission
- Device name
- Invisalign System
- Applicant
- Align Technology, Inc.
San Jose, CA, US - Received
- February 1, 2022
- Decision date
- April 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K193659 | iTero Element 5DNTK · Traditional | 03/20/2020SE |
Questions and answers
When was Invisalign System cleared by the FDA?
Invisalign System (K220287) received a 510(k) decision of Substantially Equivalent on April 7, 2022, 65 days after the submission was received.
What is the product code of K220287?
The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.