Precision Align
FDA 510(k) K212772 · Precision Align, LLC
510(k) numberK212772
Submission
- Device name
- Precision Align
- Applicant
- Precision Align, LLC
Fort Lauderdale, FL, US - Received
- August 31, 2021
- Decision date
- January 15, 2022
- 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 |
Questions and answers
When was Precision Align cleared by the FDA?
Precision Align (K212772) received a 510(k) decision of Substantially Equivalent on January 15, 2022, 137 days after the submission was received.
What is the product code of K212772?
The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.