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Invisalign Specifix Attachment System is a directly fabricated accessory indicated to bond attachments and/or engagement features to apply force for tooth movement during orthodontic treatment of malocclusion, and/or for retention of Align orthodontic appliances.

Align Technology, Inc. is submitting this Special 510(k) to modify Align's Invisalign Pre-Formed Attachment System (PFA) cleared in 510(k) K222894. The brand name of subject (modified) device is Invisalign Specifix Attachment System.

Invisalign Specifix Attachment System is a doctor prescribed 3D-printed device intended to bond 3D-printed attachments and/or engagement features to the patient's teeth. Invisalign Specifix attachments apply force for tooth movement along with Invisalign System aligner during the orthodontic treatment of malocclusion, and/or support retention of Align orthodontic appliances. The engagement features are intended to engage with commercially available orthodontic elastics and ligatures. Invisalign Specifix Attachment System is designed based on the doctor/dental practitioner's prescription and patient's anatomical tooth surface. The dentition-matched Invisalign Specifix System allows dental practitioner to seat the device on the patient's unique dentition, and facilitates placement of attachments and/or engagement features during bonding and are removable post bonding.

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