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Clear Aligner is indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion.

The first step is to obtain the dimensions and details of the patient's upper and lower dentition from the prescribing clinician who takes impressions or scans of the patient's teeth and sends them to the lab. The scanned data (oral scans or printed models) are imported into specialized dental software for treatment planning.

The second step is to send the treatment plan to the dentist for review and approval, then print the 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, we utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the corresponding molds needed for this series of sequential models, and hot-press the molds into the corresponding aligners.

The final step is to thermoform the printed mold through a plastic sheet. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. The thermoformed aligners are then sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation in this submission is the 3shape Ortho System™.

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Celebrace software is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include orthodontic devices (orthodontic wires, orthodontic brackets and bonding trays).

To use Celebrace Software, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.

Celebrace software is a software only device that creates an orthodontic treatment plan. The input to Celebrace Software are a combination of Intraoral Scans, CBCT radiographs and patient demographics. The output of the Celebrace Software is a treatment plan, which is approved by the treating dentist, and files used for physical manufacturing of the orthodontic devices (orthodontic wires, brackets and bonding tray). The software is powered by a static algorithm that is locked at the time of release.

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The Carriere® Motion Pro® Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment.

The Carriere Motion Pro Clear Bite Corrector is a single-use, direct bond, esthetic orthodontic appliance made of 17-4 stainless steel and polyethersulfone. It attaches the maxillary or mandibular canine or 1st premolar to the molar to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. The Carriere Motion Pro Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment. An optional drop-in hook, manufactured from 304 stainless steel, is included and is intended to work in conjunction with the Carriere Motion Pro Clear appliance to facilitate attachment of various orthodontic auxiliaries, such as elastomeric chain, nitinol springs, ligature wire, and elastics.

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LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics.

LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant.

LuxCreo Flexible Partial Denture (FPD) Resin is a state of the art resin engineered specifically for the 3D Printing of digitally designed flexible partial denture bases. The FPD resin utilizes LuxCreo's Digital Polishing platform to deliver clear, accurate, and biocompatible partial dentures in a single session with minimal need for finishing.

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Primeprint Aligner is a light curing resin intended for the treatment of tooth malocclusion in patients with developed permanent dentition. Primeprint Aligner repositions teeth by way of continuous gentle force.

Intended place of use: Orthodontic/dental practices/clinics, dental laboratories

Primeprint Direct Aligner is a light-curing material for the production of aligners using the Primeprint Solution (Primeprint 385nm DLP 3D printer and Primeprint Post Processing Unit). The material is intended for the treatment of tooth malocclusion in patients with developed permanent detention. Primeprint Direct Aligner repositions teeth by way of continuous gentle force.

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The Invisalign® Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition and during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

The Invisalign® Palatal Expander (IPE) System (subject device) consists of a series of doctor prescribed, additive manufactured (3D Printed), removable orthodontic appliances (Invisalign® Palatal Expanders and Invisalign® Palatal Holders), and proprietary Align internal personnel facing shape operating 3D Orthodontic Software. The IPE System is indicated for the orthodontic treatment of malocclusion. The System is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed (primary and permanent), or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, the IPE System is to be used in conjunction with surgery or other interventions when necessary. The proprietary 3D Orthodontic Software creates digital files for IPE System to be manufactured using digital data from the doctor/dental practitioner's prescription and patient scans. This submission adds an optional engagement feature to the existing Invisalign Palatal Expander System. Engagement features support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion.

This submission adds an optional engagement feature to the existing Invisalign® Palatal Expander System (K232887). The proposed addition of engagement feature to the System is similar to the reference device, Invisalign System (K252380). Engagement features are designed to provide an anchor point to support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion without altering the principle of operation of the device. The engagement features can be either forward facing or backward facing per the doctor's treatment plan. The IPE System with engagement features are additive manufactured using the same material as the predicate device (proprietary thermoplastic polyamide) and use the same manufacturing process as the predicate device.

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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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The Serafin is intended for the orthodontic treatment of malocclusion in patients with mixed and permanent dentition.

Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.

The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.

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The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

The subject device Invisalign® System is a proposed modification to add integrated button, an optional feature into the predicate device, Invisalign System (K241412). The Invisalign® System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. This submission adds an optional integrated button to aligners which is similar to the predicate device's precision cut feature that allows doctors to add orthodontic accessories such as elastics during treatment. The 3D treatment planning software allows the visualization and button placement on the aligners. The doctor still approves the treatment plan prior manufacturing, which is the same as that in the predicate.

Like the predicate device, the Invisalign® System consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The optional MAF positions patients jaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. There are no changes introduced to the user workflow other than the addition of optional integrated button feature.

This FDA 510(k) clearance letter describes a modification to an existing medical device, the Invisalign System. It does not contain the detailed information typically found in a study report for proving device performance against acceptance criteria, especially for AI/software devices. The provided text primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device for an additional physical feature (integrated button) rather than a software-driven performance claim that would necessitate a rigorous clinical or performance study with acceptance criteria and specific test methodologies for AI.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document because such a study, in the context of an AI/software device, does not appear to be the primary focus of this specific 510(k) submission as presented. The submission is for a physical device modification, not a new AI algorithm.

However, based on the information provided, here's what can be inferred or stated that such an approval did not involve:

Summary of Device Performance Study Based on Provided Text:

This 510(k) clearance letter for the Invisalign System (K252380) primarily concerns a modification to an existing device, specifically the addition of an "integrated button" feature to the aligners. The regulatory pathway is based on substantial equivalence to a predicate device (Invisalign System, K241412). The "study" described is a set of non-clinical tests to demonstrate that this physical modification does not negatively impact the device's safety and effectiveness. It does not present a study proving the performance of an AI/software component against acceptance criteria in the typical sense of a diagnostic or therapeutic AI device.

Therefore, most of the requested information regarding AI algorithm performance (e.g., sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or not provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The subject device, Invisalign® System underwent a complete set of functional and performance testing, including durability, shear bond, retention, and biocompatibility testing. All testing passed acceptance criteria and demonstrated the device modification does not affect the safety and effectiveness of Invisalign® System and does not raise any new questions of safety and effectiveness."

However, the specific quantitative acceptance criteria and the corresponding reported performance values for these tests (durability, shear bond, retention, biocompatibility) are not detailed in this 510(k) summary. These are typically listed in an internal test report, not the public-facing FDA clearance letter.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (since the tests are physical and chemical, not clinical data for an AI algorithm).
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. The described tests (durability, shear bond, retention, biocompatibility) are laboratory-based engineering and materials tests, not clinical evaluations requiring expert consensus on a test set of patient data as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This document does not mention an MRMC study. The device modification is a physical feature (integrated button) and its impact on human readers or clinical interpretation in an AI-assisted workflow is not discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No, not in the context of AI algorithm performance. The "Invisalign System" does include "proprietary 3D treatment planning software," and this submission notes the software allows "visualization and button placement on the aligners." However, the 510(k) focuses on the physical button's safety and effectiveness, not a new or modified AI algorithm's standalone performance. The software's role is described as "the doctor still approves the treatment plan prior manufacturing," indicating a human-in-the-loop scenario. No standalone algorithm performance evaluation is detailed.

7. The Type of Ground Truth Used:

• For the physical tests (durability, shear bond, retention, biocompatibility): The ground truth would be established through scientific measurement standards and validated laboratory methodologies (e.g., ISO standards for materials testing).
• For any software component related to the new feature: The ground truth for software functionality (e.g., correct button placement visualization, accurate manufacturing instructions) would internally be established through testing against design specifications and requirements. This is not detailed in the document.

8. The Sample Size for the Training Set:

• Not Applicable/Not Specified. This document does not describe the development or training of a new AI algorithm. If the "proprietary 3D treatment planning software" utilizes machine learning, its training set details are not provided as part of this specific 510(k) for a physical modification.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable/Not Specified. See point 8.

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