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510(k) Data Aggregation
K Number
K241412Device Name
Invisalign System
Manufacturer
Align Technology, Inc.
Date Cleared
2024-06-18
(32 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.
Device Description
The subject device, Invisalign System, is a modification to the predicate device, Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233, cleared on September 26, 2023) to introduce an additional treatment planning workflow that does not require any Align Computer Aided Design (CAD) technician interaction. The Invisalign System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. As part of this submission, there are no proposed design changes made to standard aligners or aligners with Mandibular Advancement Features (MAF) since the clearance of K232233. Further, there are no proposed changes to the proprietary 3D treatment planning software except for the non-significant changes that were implemented via Letter to File.
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.
The proposed modification in this premarket notification is to add a completely automated endto-end treatment planning workflow without CAD technician involvement. The subject device, Invisalign System, is the Invisalign System aligners produced with the additional treatment planning workflow.
There are no proposed design changes to the Invisalign System components as part of this submission.
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K Number
K232887Device Name
Invisalign Palatal Expander System
Manufacturer
Align Technology, Inc.
Date Cleared
2023-12-15
(88 days)
Product Code
NXC, DYJ, K93
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 tooth, palate) with primary, mixed, or permanent dention during orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.
Device Description
The subject device, Invisalign Palatal Expander (IPE) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices. Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary.
The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software.
Invisalign Palatal Expanders are a staged series of removable orthodontic devices designed to expand the patient's skeletal and/or dental narrow maxilla (upper jaw, dental arch, teeth and palate) in small increments to an optimal position determined by the doctor. Once the desired clinical outcome of the expansion phase has been achieved, patients progress to the holding phase.
The Invisalign Palatal Holder is a copy of the last stage of the expansion phase designed to hold the maxilla post active expansion, to allow the maxilla to stabilize before the patient progresses to the next phase of treatment (retention, phase 2 or other treatment).
The proprietary Align internal personnel-facing 3D software enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device. Using this software, CAD designers create digital files for the incremental stages of the doctorprescribed expansion amount and the design and quantity of holders per the prescribed holding duration. Each device in the series is fabricated via additive manufacturing (3D printing).
The Attachment Template (also a component of the primary predicate device, the Invisalign System) enables correct placement and bonding of attachments made of dental composite (material provided by doctor) to the tooth surface for IPE engagement and retention.
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K Number
K232233Device Name
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Manufacturer
Align Technology, Inc.
Date Cleared
2023-09-26
(61 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The subject device, Invisalian System with Mandibular Advancement Featuring Occlusal Blocks (Invisalign System, MAOB) is a modification to the predicate device, Invisalign System (K220287, cleared on April 07, 2022) and the reference device. Invisalign System with Mandibular Advancement Features (K181739, cleared on October 26th, 2018). The Invisalign System, MAOB (subject device) consists of removable orthodontic appliances (aligners with mandibular advancement features including occlusal blocks), proprietary treatment planning 3D software (doctor facing - ClinCheck and Align employee facing -Treat) and attachment templates.
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K Number
K222894Device Name
Invisalign System, Pre-Formed Attachment System
Manufacturer
Align Technology, Inc.
Date Cleared
2022-12-22
(90 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invisalign System is intended for the orthodontic treatment of malocclusion.
Device Description
The subject device, Invisalign System with Pre-Formed Attachments (PFA) System, is a modification to the predicate device, the Invisalign System (K220287, cleared on April 7th, 2022). The Invisalign System with PFA system consists of removable orthodontic appliances (aligners), proprietary treatment planning 3D software, attachment templates and/or PFA system.
Like the predicate device, the Invisalign system with PFA (subject device) 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 dental malocclusion. The Invisalian system aligners are used in patients with primary, mixed (primary and permanent), and permanent dentition. The Invisalign system aligners with mandibular advancement feature(s) are used in patients with mixed and permanent dentition to correct Class II malocclusions. The Invisalign system is intended to treat dental and skeletal malocclusion in patients with Class I, II and III including Antero-Posterior (A-P), vertical (open bite, deep bite), transverse (narrow arch or jaw, crossbite), or inter-arch (spacing and crowding) correction at all severity levels. In some cases, surgical intervention, or addition of other appliances in addition to Invisalign treatment may be needed at the doctor's discretion.
The proprietary ClinCheck (CC) 3-D software is inclusive of both dental practitioner-facing functions and internal Align personnel-facing functions. The Align facing software enables Align's computer-aided design (CAD) designers to create a treatment plan based on a doctor's prescription and inputs (e.g., dental scans). The treatment plans created using the Align personnel-facing software are then reviewed and approved by doctors before the aligners are manufactured. The doctors' reviews and approvals are exchanged via ClinCheck software (dental practitioner-facing software). Once the treatment plan is approved by the dental practitioner, the information is sent to the manufacturing facility for creation of the aligners.
When attachments are prescribed as part of the treatment plan, the subject device has the option of delivering them preformed with PFA system or with a disposable attachment template. The attachment templates are disposable polyurethane appliances which match the patient's existing dentition and include wells for the placement of dental composite (sold separately). During the first visit, the dental practitioner uses the template in bonding dental composite to the tooth surface to create attachments on the teeth. These attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement.
The PFAs are made of a fully cured proprietary photo-polymerizable methacrylate-based resin (similar to dental composite material). PFA system is intended to enable correct placement of attachments and bond attachments to the tooth surface for aligner retention and to optimize aligner force system for tooth movement.
The patient-customized PFA are manufactured using additive manufacturing technologies and configured to individual patient's treatment plans and teeth anatomy using a proprietary internal facing 3D device-generation manufacturing software.
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K Number
K220287Device Name
Invisalign System
Manufacturer
Align Technology, Inc.
Date Cleared
2022-04-07
(65 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invisalign System is intended for the orthodontic treatment of malocclusion.
Device Description
The Invisalign System (subject device) consists of removable orthodontic appliances (aligners), proprietary 3D software and attachment template. The 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 mandibular advancement feature positions patients iaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. The Invisalign System is intended for treating dental and skeletal malocclusion in patients with Class I, II and III including Antoro-Posterior (A-P), vertical (open bite, transverse (narrow arch or jaw, crossbite), or inter-arch (spacing and crowding) correction at all severity levels. In some cases, surgical intervention, or addition of other appliances in addition treatment may be needed at the doctor's discretion.
The Invisalign System aligners consist of a series of customized orthodontic devices made from proprietary thermoformed polyurethane sheeting material. The first device in the series matches the patient's dentition in its current state and then each subsequent aligner stage has the shape of the dentition shifted gradually toward the final desired position. The aligners can accommodate use of tooth attachments and elastics (through use of precision cut outs or buttons or power arms). The system can also be ordered with additional aligner features such as precision cut outs, bite ramps, compliance indicators, and mandibular advancement features (MAF). MAF is also referred to as precision wings and is prescribed by the dental practitioner to position the lower jaw forward during correction of skeletal malocclusion. The subject device system of this Special 510(k), referred to as the Invisalign System, is a modification to the predicate device the Invisalign System with Mandibular Advancement Feature (MAF) (K181739, cleared on Oct 26, 2018) and is inclusive of both standard aligners and aligners with mandibular advancement feature.
The proprietary ClinCheck (CC) 3-D software is inclusive of both dental practitioner-facing functions and internal Align personnel-facing functions. The Align personnel-facing functions are termed 'Treat' internally. This internal facing software enables Align's computer-aided design (CAD) designers to create a treatment plan based on a doctor's prescription and inputs (e.g., dental scans). The treatment plans created using the Align personnel-facing software are then reviewed and approved by doctors before the aligners are manufactured. The doctors' reviews and approvals are exchanged via ClinCheck software (dental practitioner-facing software). Once the treatment plan is approved by the dental practitioner, the information is sent to the manufacturing facility for creation of the aligners.
When attachments are prescribed as part of the treatment plan, a disposable template is provided to assist the dental practitioner in positioning and forming the attachments from dental composite (sold separately). Attachment templates are disposable polyurethane appliances which match the patient's existing dentition and include wells for the placement of dental composite. During the first visit, the dental practitioner uses the template in bonding dental composite to the tooth surface to create attachments on the teeth. These attachments help create forces on the tooth which can assist in aligner retention or optimized aligner force system for tooth movement.
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K Number
K193659Device Name
iTero Element 5D
Manufacturer
Align Technology, Inc.
Date Cleared
2020-03-20
(81 days)
Product Code
NTK
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iTero Element 5D is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
Device Description
The iTero Element 5D is an integrated intraoral imaging system capable of 3D confocal optical impressions for CAD/CAM of dental devices, which also captures 2D color images and Near Infrared (NIR) images.
The iTero Element 5D consists of a scanning wand cradle, single-use, disposable, 5D barrier sleeve, iTero Element 5D Sleeve (protective sleeve), software (including GUI), and a computer hardware platform that is offered in two configurations:
1. Laptop Configuration, where the GUI is presented on a customer-provided PC Laptop Touchscreen;
2. Wheel Stand Configuration where the GUI is presented on a display panel that is mounted on a wheel stand base unit.
The scanning wand and software, including the GUI, are common to both configurations.
The scanning wand which has 3 imaging capabilities: 1) 3D confocal optical impression, 2) 2D color imaging and 3) near infrared imaging (NIRI), is designed to be used with a single-use, disposable, scanning wand barrier sleeve ("5D barrier sleeve") during scans and a protective sleeve during storage. At the beginning of every scan, the single-use, disposable, 5D barrier sleeve is placed on the scanning wand's head. The wand tip is placed slightly above the patient's teeth and the scan is initiated. At the end of the scan, proprietary imaging software converts the scan into an image that is simultaneously presented alongside the 2D color images on the GUI display. The 3D confocal optical impression and 2D color images assist in orientation by providing an enhanced view of the scanned teeth, thus helping the user identify which areas (i.e. occlusal direction/angles) to view as NIR images. The 2D color image displays a close-up view of the teeth while the NIR Image translates the teeth structure (enamel and dentin) to different brightness levels.
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K Number
K181739Device Name
Invisalign System with Mandibular Advancement Feature
Manufacturer
Align Technology, Inc.
Date Cleared
2018-10-26
(116 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Align Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invisalign System is indicated for the orthodontic treatment of malocclusion.
Device Description
The Proposed Device is a minor change to the currently marketed Invisalign System (K143630) (hereafter referred to as "Predicate Device") to support repositioning of the mandible.
Invisalign System with Mandibular Advancement Feature consists of a series of doctor prescribed, customized, thin, clear plastic, removable orthodontic appliances (aligners) and proprietary ClinCheck 3-D software. The aligners gently move the patient's teeth in small increments and position the mandible forward from their original state to a more optimal, treated state. The Proposed Device treats patients with Class 1 and Class 2 malocclusion as well as patients with severe open bite, severe overiet, deep bite, skeletally narrow jaw, dental prostheses/implants. and/or those who require surgical correction. The Proposed Device includes two mandibular advancement features, also known as "precision wings", on each upper and lower aligner that function as mandibular repositioners, maintaining the lower jaw in the forward position.
The Proposed Device is made from the same material and utilizes the same manufacturing processes as the Predicate Device, Invisalign System (K143630). The software level of concern for the Predicate Device is moderate. Minor updates have been made to the proprietary ClinCheck 3-D software to enable placement of the mandibular advancement features on the aligners during the MA Phase of treatment. The software level of concern for the Proposed Device is determined to be the same as the Predicate Device: moderate.
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K Number
K143630Device Name
Invisalign System
Manufacturer
ALIGN TECHNOLOGY, INC.
Date Cleared
2015-11-18
(331 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
ALIGN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Device Description
The Invisalign System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Invisalign System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary Invisalign System 3-D software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are then manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
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