The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.

Device Description

The Byte Aligner System consists of a sequential series of aligners fabricated of clear, thin, lightweight and flexible thermoformed polyethylene terephthalate glycol (PETG) [copolyester] plastics. The mechanism of action of the proposed Byte Aligner System is mechanical in nature; that is, tooth movement induced by orthodontic force application using continuous gentle forces. The aligners are made from elastic thermoplastic material that applies continuous gentle force to the teeth for treatment of tooth malocclusion. Treatment plans are modeled using CAD-CAM (computer-aided-design and computer-aided-manufacturing) software. Model archforms are created using rapid prototyping techniques like stereo-lithography. The aligners are thermoformed over the model archforms and are not themselves 3D printed. With the aligners seated on the patient's upper and/or lower dental arches, the teeth are progressively and gradually straightened over time by mechanical forces that are delivered via minor, incremental changes in tooth positions in each subsequent set of aligner trays that have been customized for the patient, delivered as a sequential series of trays to progressively reposition the teeth. The mechanics of how this happens is based on the forces caused by the elastic deformation of the aligner when worn by the patient. The forces are applied to the teeth, and also to the roots, causing pressure to the periodontium in the direction of the desired movement. Each aligner moves the patient's teeth in small increments from their original state.

AI/ML Overview

The furnished document is a 510(k) Summary for the Byte Aligner System (K230199). It is a declaration of substantial equivalence to a predicate device, not a report detailing a clinical study with acceptance criteria for an AI-powered device. Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria is not present in the provided text.

Specifically:

No acceptance criteria or device performance report: The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance, nor does it present reported device performance metrics against such criteria.
No test set details: There is no mention of a test set size, data provenance, or whether the study was retrospective or prospective.
No expert adjudication details: The document does not discuss the number or qualifications of experts used for establishing ground truth, nor does it specify any adjudication methods.
No MRMC study: There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or any effect size for human readers improving with AI assistance.
No standalone performance: The document does not report on the standalone performance of an algorithm without human intervention.
No ground truth type: The type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not specified because a study of this nature was apparently not performed.
No training set details: There is no information about the sample size of a training set or how ground truth for a training set was established.

The 510(k) Summary primarily focuses on demonstrating substantial equivalence of the modified Byte Aligner System (K230199) to its predicate device (K180346) and reference devices by comparing their intended use, indications for use, technological characteristics, and safety aspects (biocompatibility, shelf-life, material review). It explicitly states: "No data from human clinical studies was included to support the substantial equivalence of the proposed Byte Aligner System." Therefore, it's not possible to extract the requested information from this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2023

Dentsply Sirona Inc. Sobrin Laura Corporate RA Manager 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K230199

Trade/Device Name: Byte Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 25, 2023 Received: January 25, 2023

Dear Sobrin Laura:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230199

Device Name

Byte Aligner System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY For Byte Aligner System (K230199)

1. Submitter Information:
  Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404

Contact Person: Laura Sobrin Telephone Number: 717-849-4434 Fax number: 717-849-4343

Date Prepared: October 13, 2023

2. Device Name:

Proprietary Name: Byte Aligner System ●
Classification Name: Orthodontic plastic bracket ●
CFR Number: 21 CFR 872.5470 .
Device Class: Class II ●
Product Code: NXC, Aligner, Sequential .

3. Predicate & Reference Devices:

Device Name	Device Type	510(k)	Company Name
Byte Aligner System	Predicate	K180346	Straight Smile, LLC (part ofDentsply Sirona)
Sureclear Aligners	Reference	K171860	OraMetrix (part of DentsplySirona), now Dentsply SironaOrthodontics Inc.
Mouthguard and AlignerMaterials	Reference	K062828	Dentsply International (part ofDentsply Sirona), nowDentsply Sirona OrthodonticsInc.
Invisalign System withMandibularAdvancement Feature	Reference	K181739	Align Technology Inc.

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Device Name	Device Type	510(k)	Company Name
Ormco Spark AlignerSystem	Reference	K182826	Sybron Dental Specialties

4. Description of Device:

The Byte Aligner System consists of a sequential series of aligners fabricated of clear, thin, lightweight and flexible thermoformed polyethylene terephthalate glycol (PETG) [copolyester] plastics.

The mechanism of action of the proposed Byte Aligner System is mechanical in nature; that is, tooth movement induced by orthodontic force application using continuous gentle forces. The aligners are made from elastic thermoplastic material that applies continuous gentle force to the teeth for treatment of tooth malocclusion. Treatment plans are modeled using CAD-CAM (computer-aideddesign and computer-aided-manufacturing) software. Model archforms are created using rapid prototyping techniques like stereo-lithography. The aligners are thermoformed over the model archforms and are not themselves 3D printed.

With the aligners seated on the patient's upper and/or lower dental arches, the teeth are progressively and gradually straightened over time by mechanical forces that are delivered via minor, incremental changes in tooth positions in each subsequent set of aligner trays that have been customized for the patient, delivered as a sequential series of trays to progressively reposition the teeth. The mechanics of how this happens is based on the forces caused by the elastic deformation of the aligner when worn by the patient. The forces are applied to the teeth, and also to the roots, causing pressure to the periodontium in the direction of the desired movement. Each aligner moves the patient's teeth in small increments from their original state.

న. Indications for Use:
The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.

6. Comparison of Technological Characteristics:

The purpose of this Traditional 510(k) is to gain U.S. premarket clearance for the modification to the predicate device Byte Aligner System (K180346).

. The proposed and predicate device have the same intended use, patient population and indications for use.
The proposed and predicate devices are made by thermoforming PETG (copolyester) plastic sheets.
The proposed and predicate devices have the same packaging configurations. ●

The key differences between the predicate device (K180346) and the proposed device are:

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The proposed device can be made by thermoforming additionally cleared PETG (copolyester) ● plastic sheets (K062828), and which follows the same manufacturing processes and materials as reference device Sureclear Aligners (K171860).
. Reference to two additional cleared orthodontic software systems (K213916, K171860) that can be used for treatment planning software prior to the fabrication of the proposed device.
Revise product label to only include date of manufacture and exclude an expiration date to be . consistent with the reference device Sureclear Aligners (K171860).
Separate Instructions for Use for patient and doctor. Update patient Instructions for Use to be . more aligned with requirements in FDA guidance document, "Guidance on Medical Device Patient Labeling". Create separate Instructions for Use geared towards the dentist.
. Allow for the use of cut-outs, slits and attachments similar to the reference devices (K181739 and K182826).

An overview of the similarities and differences between the proposed devices, predicate device, and reference devices is given in Table FS.1.

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Item ofComparison	Proposed deviceByte AlignerSystem(K230199)	Predicate deviceByte AlignerSystem (K180346)	Reference deviceSureclear Aligners(K171860)	Reference deviceEssix plasticsheets (K062828)	Reference deviceInvisalign Systemwith MandibularAdvancementFeature(K181739)	Reference deviceOrmco SparkAligner System(K182826)	Discussion
Manufacturer	Straight Smile,LLC (part ofDentsply Sirona)	Straight Smile,LLC (part ofDentsply Sirona)	OraMetrix (part ofDentsply Sirona),now DentsplySironaOrthodontics Inc.	DentsplyInternational(part of DentsplySirona), nowDentsply SironaOrthodontics Inc.	AlignTechnology, Inc.	Sybron DentalSpecialties	The proposedand predicatedevices areDentsply Sironadevices. Somereference devicesare DentsplySirona devices orthird-partydevices.
Intendedpopulation	Patients withpermanent dentition	Patients withpermanentdentition	Patients withpermanentdentition		Patients withpermanentdentition	Patients withpermanentdentition	Same
Indications forUse	The Byte AlignerSystem is indicatedfor the treatment oftooth malocclusionin patients withpermanent dentition(i.e., all secondmolars). The ByteAligner Systempositions teeth byway of continuousgentle force.	The Byte AlignerSystem isindicated for thetreatment of toothmalocclusion inpatients withpermanentdentition (i.e., allsecond molars).The Byte AlignerSystem positionsteeth by way ofcontinuous gentleforce.	Sureclear alignersare indicated forthe treatment oftooth malocclusionin patients withpermanentdentition.	Mouthguard andAligner Materialsare indicated forthe fabrication oforthodontic anddental appliancessuch as aligners,bite planes,mouthguards.nightguards,snoringappliances.splints, retainers,repositioners, andtemporarybridges.	The InvisalignSystem isindicated for theorthodontictreatment ofmalocclusion.	The Ormco™Spark™ AlignerSystem isindicated for thealignment ofteeth duringorthodontictreatment ofmalocclusion inpatients withpermanentdentition (i.e., allsecond molars).The Ormco™Spark™ AlignerSystem positionsteeth by way ofcontinuous gentleforce.	Same as thepredicate device.Similar to thereferencedevices.
Item of	Proposed device	Predicate device	Reference device	Reference device	Reference device	Reference device	Discussion
Comparison	Byte AlignerSystem(K230199)	Byte AlignerSystem (K180346)	Sureclear Aligners(K171860)	Essix plasticsheets (K062828)	Invisalign Systemwith MandibularAdvancementFeature(K181739)	Ormco SparkAligner System(K182826)
Mechanism ofaction	Sequential alignersare made from elasticthermoplasticmaterials that applycontinuous gentleforce to the teeth inthe form of storedenergy imparted inthe aligner trays atthe time of theirfabrication. Thisenergy slowlydissipates over time,and re-positions theteeth by way ofcontinuous gentleforce.	Sequential alignersare made fromelastic thermoplasticmaterials that applycontinuous gentleforce to the teeth inthe form of storedenergy imparted inthe aligner trays atthe time of theirfabrication. Thisenergy slowlydissipates over time,and re-positions theteeth by way ofcontinuous gentleforce.	Sequential alignersare made fromelastic thermoplasticmaterials that applycontinuous gentleforce to the teeth inthe form of storedenergy imparted inthe aligner trays atthe time of theirfabrication. Thisenergy slowlydissipates over time,and re-positions theteeth by way ofcontinuous gentleforce.		Sequentialaligners applycontinuous gentleforce to the teethand position themandible forward	Orthodontic toothmovement occursthrough forcesapplied by theappliance to thedentition as eachtooth follows theprogrammeddisplacementbased on a dentalclinician'sprescription.	Same as thepredicate deviceand referencedevice SureclearAligners(K171860).Similar to thereferencedevices.
Aligner TrayRaw materialused	PETG (copolyester)	PETG(copolyester)	PETG(copolyester)	Variousthermoplasticsheets includingPETG(copolyester)plastic sheets	Polyurethane-polyestercomposite resin	Polyurethane-polyestercomposite resin	Similar.Proposed deviceuses the sameplastic sheetmaterials in thepredicate deviceand referencedevice SureclearAligners(K171860).
Manufacturingprocess	Thermoformingplastic sheets over3D printed model	Thermoformingplastic sheets over3D printed model	Thermoformingplastic sheets over3D printed model	Thermoformingplastic sheetsover 3D printedmodel	Thermoformingplastic sheetsover 3D printedmodel	Thermoformingplastic sheetsover 3D printedmodel	Same
Item ofComparison	Proposed device	Predicate device	Reference device	Reference device	Reference device	Reference device	Discussion
	Byte AlignerSystem(K230199)	Byte AlignerSystem (K180346)	Sureclear Aligners(K171860)	Essix plasticsheets (K062828)	Invisalign Systemwith MandibularAdvancementFeature(K181739)	Ormco SparkAligner System(K182826)
Toothmovements	Tooth movementsavailable includethe full rangenecessary toprovide fullorthodontictreatment ofpatients withpermanentdentition, consistentwith the Indicationsfor Use.	Tooth movementsavailable includethe full rangenecessary toprovide fullorthodontictreatment ofpatients withpermanentdentition,consistent with theIndications forUse.	Tooth movementsavailable includethe full rangenecessary toprovide fullorthodontictreatment ofpatients withpermanentdentition,consistent with theIndications forUse.		Toothmovementsconsistent withthe Indicationsfor Use,includingmandibularadvancement.	Toothmovementsconsistent withthe Indicationsfor Use.	Same as thepredicate andreference device,Sureclearaligners(K171860)Similar to otherreference devices(K181739 &K182826)
Sterility state	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Same
Single Patientuse	Single patient,multiple use	Single patient,multiple use	Single patient,multiple use	Single patient,multiple use	Single patient,multiple use	Single patient,multiple use	Same
Shelf Life	No shelf life	2 years	No shelf life	No shelf life	No shelf life	No shelf life	Same as thereference devices
OTC or Rx	Rx	Rx	Rx	Rx	Rx	Rx	Same
Attachments	Available	Available	Available		Available	Available	Same
Cut-outs/Slits	Available				Available	Available	Same as thereference devices(K181739,K182826)
Item ofComparison	Proposed deviceByte AlignerSystem(K230199)	Predicate deviceByte AlignerSystem (K180346)	Reference deviceSureclear Aligners(K171860)	Reference deviceEssix plasticsheets (K062828)	Reference deviceInvisalign Systemwith MandibularAdvancementFeature(K181739)	Reference deviceOrmco SparkAligner System(K182826)	Discussion
In useduration	Aligners are wornfor 7-14 days (1-2weeks) or asdirected by thedentist. Aligners areto be worn 20-22hours (24/7) exceptwhen eating,drinking, brushingor flossing.	Each month, wearthe first set for 1week, the second setfor 1 week, and thethird set for 2weeks.	Aligners should beworn 20 to 22 hoursdaily. Each set ofaligners should bereplaced afterapproximately 2weeks of use.		Aligners areworn forapproximately 1-2 weeks of 20-22hours of wear perday. This isrepeated forduration asprescribed by thedentalpractitioner.	Aligners areworn every oneor two weeks aspart of thepersonalizedtreatment plan.	SimilarAligners areworn for 7-14days (1-2 weeks)for the proposeddevice andranges between 1to 2 weeks forthe predicate andreferencedevices. Theproposed labelingstandardizes thewear time for theend userregardless ofaligner stage andmakes it easierfor the patient toadhere to theirtray changeregimen.
Software usedfor orderingworkflow	Yes	Yes	Yes				Same

Table FS.1: Similarities and Differences between the Proposed device, Predicate device, and Reference devices

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7. Non-Clinical Performance Data

Testing data that was referenced, or data relied upon to demonstrate substantial equivalence include:

a) Biocompatibility evaluation in accordance with EN ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing with a risk management process) was performed and it was determined that no additional testing was required to demonstrate biological safety of proposed devices. Testing on file in Sureclear Aligners (K171860) remains valid.
b) Shelf-life information included in Mouthguard and Aligner Materials (K062828) and Sureclear Aligners (K171860) was reviewed, in addition to literature, and considered to be sufficient evidence to support the addition of alternate PETG (copolyester) materials and modification to the finished device shelf-life.
c) Literature and material data sheet review was performed on the predicate device (K180346) PETG polyester materials and the proposed PETG polyester materials and confirmed that the materials are very similar in characteristics and performance.

8. Clinical Performance Data

No data from human clinical studies was included to support the substantial equivalence of the proposed Byte Aligner System.

9. Conclusion

The information included in this Traditional 510(k) supports the substantial equivalence of the proposed Byte Aligner System with the predicate device Byte Aligner System (K180346). The proposed device has the same intended use and indications for use as the predicate device, and is an aligner system fabricated by thermoforming PETG (copolyester) plastics that induce tooth movement by orthodontic force application using continuous gentle forces.

The proposed device represents an extension of predicate device Byte Aligner System (K180346) by allowing for the addition of alternate PETG (copolyester) materials to be used for manufacturing of aligners and removing the shelf life of the device based on the nature of the Byte Aligner System and well-known polymer science. The technological differences between the predicate device Byte Aligner System (K180346) and the proposed device are supported with the data included in premarket notifications of reference devices Sureclear aligners (K171860) and Mouthguard and Aligner materials (K062828) and additional data provided in this submission in support of the equivalency between the polyester materials. In addition, this premarket submission incorporates slits and cut-outs into the aligner and allows for the use of attachments which is similar to the additional reference devices (K181739, K182826).

Based on the intended use, indications for use, and technological features comparison, and the review of literature, data on file, and testing by reference, it can be concluded that the proposed Byte Aligner System is substantially equivalent to the predicate device Byte Aligner System (K180346).

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.