Clear Aligner
FDA 510(k) K223517 · Wuxi EA Medical Instruments Technologies Limited.
510(k) numberK223517
Submission
- Device name
- Clear Aligner
- Applicant
- Wuxi EA Medical Instruments Technologies Limited.
Wuxi, CN - Received
- November 23, 2022
- Decision date
- June 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K203688 | Clear AlignerNXC · Traditional | 10/08/2021SE |
Questions and answers
When was Clear Aligner cleared by the FDA?
Clear Aligner (K223517) received a 510(k) decision of Substantially Equivalent on June 13, 2023, 202 days after the submission was received.
What is the product code of K223517?
The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.