Align Technology, Inc. · Class II · Cleared Oct 9, 2025
| K-number | K252870 |
| Device name | Invisalign Specifix Attachment System |
| Applicant | Align Technology, Inc. |
| Product code | NXC |
| Device class | Class II |
| Decision date | Oct 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.5470 |
The Invisalign Specifix Attachment System is a 3D-printed orthodontic accessory that bonds attachments and engagement features to teeth to apply force for tooth movement during orthodontic treatment of malocclusion and for retention of Align orthodontic appliances. The device is dentition-matched and prescription-based, designed to engage with commercial orthodontic elastics and ligatures.
The subject device differs from the predicate by using different material composition, including engagement features to engage with orthodontic accessories like elastics and ligatures, ability to provide retention for multiple Align orthodontic appliances (versus predicate's single Invisalign aligner retention), and modified packaging for enhanced transport integrity.
Not stated in this summary. The document references FDA guidance documents on additive manufactured devices and denture base resins but does not cite specific ISO, IEC, or ASTM standards.
View the full FDA submission: accessdata.fda.gov