Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical forces and CAD-CAM software for treatment planning and aligner fabrication, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for the treatment of tooth malocclusion, which is a medical condition, and it functions by applying continuous gentle force to reposition teeth, directly affecting the body's structure for therapeutic purposes.

Diagnostic

No
The device is described as a system for treating tooth malocclusion by physically repositioning teeth, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of physical aligners made of plastic and that the mechanism of action is mechanical. While software is used in the design process (CAD-CAM), the final medical device delivered to the patient is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, the Byte Aligner System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Byte Aligner System Function: The Byte Aligner System is a medical device used to physically move teeth to correct malocclusion. It works through mechanical force applied directly to the teeth.
Lack of Specimen Analysis: The description of the Byte Aligner System does not involve the analysis of any biological specimens from the patient. Its function is entirely external and mechanical.

The device description clearly outlines its purpose as a physical appliance for tooth movement, not a tool for analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NXC

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-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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth, dental arches

Indicated Patient Age Range

patients with permanent dentition (i.e., all second molars)

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Non-Clinical Performance Data:

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.
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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180346

Reference Device(s)

K171860, K062828, K181739, K182826

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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.

1

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)

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.

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 of
Dentsply Sirona)
Sureclear Aligners	Reference	K171860	OraMetrix (part of Dentsply
Sirona), now Dentsply Sirona
Orthodontics Inc.
Mouthguard and Aligner
Materials	Reference	K062828	Dentsply International (part of
Dentsply Sirona), now
Dentsply Sirona Orthodontics
Inc.
Invisalign System with
Mandibular
Advancement Feature	Reference	K181739	Align Technology Inc.

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Device Name	Device Type	510(k)	Company Name
Ormco Spark Aligner
System	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 of
Comparison | Proposed device
Byte Aligner
System
(K230199) | Predicate device
Byte Aligner
System (K180346) | Reference device
Sureclear Aligners
(K171860) | Reference device
Essix plastic
sheets (K062828) | Reference device
Invisalign System
with Mandibular
Advancement
Feature
(K181739) | Reference device
Ormco Spark
Aligner System
(K182826) | Discussion |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Straight Smile,
LLC (part of
Dentsply Sirona) | Straight Smile,
LLC (part of
Dentsply Sirona) | OraMetrix (part of
Dentsply Sirona),
now Dentsply
Sirona
Orthodontics Inc. | Dentsply
International
(part of Dentsply
Sirona), now
Dentsply Sirona
Orthodontics Inc. | Align
Technology, Inc. | Sybron Dental
Specialties | The proposed
and predicate
devices are
Dentsply Sirona
devices. Some
reference devices
are Dentsply
Sirona devices or
third-party
devices. |
| Intended
population | Patients with
permanent dentition | Patients with
permanent
dentition | Patients with
permanent
dentition | | Patients with
permanent
dentition | Patients with
permanent
dentition | Same |
| 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. | 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. | Sureclear aligners
are indicated for
the treatment of
tooth malocclusion
in patients with
permanent
dentition. | Mouthguard and
Aligner Materials
are indicated for
the fabrication of
orthodontic and
dental appliances
such as aligners,
bite planes,
mouthguards.
nightguards,
snoring
appliances.
splints, retainers,
repositioners, and
temporary
bridges. | The Invisalign
System is
indicated for the
orthodontic
treatment of
malocclusion. | The Ormco™
Spark™ Aligner
System is
indicated for the
alignment of
teeth during
orthodontic
treatment of
malocclusion in
patients with
permanent
dentition (i.e., all
second molars).
The Ormco™
Spark™ Aligner
System positions
teeth by way of
continuous gentle
force. | Same as the
predicate device.
Similar to the
reference
devices. |
| Item of | Proposed device | Predicate device | Reference device | Reference device | Reference device | Reference device | Discussion |
| Comparison | Byte Aligner
System
(K230199) | Byte Aligner
System (K180346) | Sureclear Aligners
(K171860) | Essix plastic
sheets (K062828) | Invisalign System
with Mandibular
Advancement
Feature
(K181739) | Ormco Spark
Aligner System
(K182826) | |
| Mechanism of
action | Sequential aligners
are made from elastic
thermoplastic
materials that apply
continuous gentle
force to the teeth in
the form of stored
energy imparted in
the aligner trays at
the time of their
fabrication. This
energy slowly
dissipates over time,
and re-positions the
teeth by way of
continuous gentle
force. | Sequential aligners
are made from
elastic thermoplastic
materials that apply
continuous gentle
force to the teeth in
the form of stored
energy imparted in
the aligner trays at
the time of their
fabrication. This
energy slowly
dissipates over time,
and re-positions the
teeth by way of
continuous gentle
force. | Sequential aligners
are made from
elastic thermoplastic
materials that apply
continuous gentle
force to the teeth in
the form of stored
energy imparted in
the aligner trays at
the time of their
fabrication. This
energy slowly
dissipates over time,
and re-positions the
teeth by way of
continuous gentle
force. | | Sequential
aligners apply
continuous gentle
force to the teeth
and position the
mandible forward | Orthodontic tooth
movement occurs
through forces
applied by the
appliance to the
dentition as each
tooth follows the
programmed
displacement
based on a dental
clinician's
prescription. | Same as the
predicate device
and reference
device Sureclear
Aligners
(K171860).
Similar to the
reference
devices. |
| Aligner Tray
Raw material
used | PETG (copolyester) | PETG
(copolyester) | PETG
(copolyester) | Various
thermoplastic
sheets including
PETG
(copolyester)
plastic sheets | Polyurethane-
polyester
composite resin | Polyurethane-
polyester
composite resin | Similar.
Proposed device
uses the same
plastic sheet
materials in the
predicate device
and reference
device Sureclear
Aligners
(K171860). |
| Manufacturing
process | Thermoforming
plastic sheets over
3D printed model | Thermoforming
plastic sheets over
3D printed model | Thermoforming
plastic sheets over
3D printed model | Thermoforming
plastic sheets
over 3D printed
model | Thermoforming
plastic sheets
over 3D printed
model | Thermoforming
plastic sheets
over 3D printed
model | Same |
| Item of
Comparison | Proposed device | Predicate device | Reference device | Reference device | Reference device | Reference device | Discussion |
| | Byte Aligner
System
(K230199) | Byte Aligner
System (K180346) | Sureclear Aligners
(K171860) | Essix plastic
sheets (K062828) | Invisalign System
with Mandibular
Advancement
Feature
(K181739) | Ormco Spark
Aligner System
(K182826) | |
| Tooth
movements | Tooth movements
available include
the full range
necessary to
provide full
orthodontic
treatment of
patients with
permanent
dentition, consistent
with the Indications
for Use. | Tooth movements
available include
the full range
necessary to
provide full
orthodontic
treatment of
patients with
permanent
dentition,
consistent with the
Indications for
Use. | Tooth movements
available include
the full range
necessary to
provide full
orthodontic
treatment of
patients with
permanent
dentition,
consistent with the
Indications for
Use. | | Tooth
movements
consistent with
the Indications
for Use,
including
mandibular
advancement. | Tooth
movements
consistent with
the Indications
for Use. | Same as the
predicate and
reference device,
Sureclear
aligners
(K171860)
Similar to other
reference devices
(K181739 &
K182826) |
| Sterility state | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Patient
use | 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 the
reference 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 the
reference devices
(K181739,
K182826) |
| Item of
Comparison | Proposed device
Byte Aligner
System
(K230199) | Predicate device
Byte Aligner
System (K180346) | Reference device
Sureclear Aligners
(K171860) | Reference device
Essix plastic
sheets (K062828) | Reference device
Invisalign System
with Mandibular
Advancement
Feature
(K181739) | Reference device
Ormco Spark
Aligner System
(K182826) | Discussion |
| In use
duration | Aligners are worn
for 7-14 days (1-2
weeks) or as
directed by the
dentist. Aligners are
to be worn 20-22
hours (24/7) except
when eating,
drinking, brushing
or flossing. | Each month, wear
the first set for 1
week, the second set
for 1 week, and the
third set for 2
weeks. | Aligners should be
worn 20 to 22 hours
daily. Each set of
aligners should be
replaced after
approximately 2
weeks of use. | | Aligners are
worn for
approximately 1-
2 weeks of 20-22
hours of wear per
day. This is
repeated for
duration as
prescribed by the
dental
practitioner. | Aligners are
worn every one
or two weeks as
part of the
personalized
treatment plan. | Similar
Aligners are
worn for 7-14
days (1-2 weeks)
for the proposed
device and
ranges between 1
to 2 weeks for
the predicate and
reference
devices. The
proposed labeling
standardizes the
wear time for the
end user
regardless of
aligner stage and
makes it easier
for the patient to
adhere to their
tray change
regimen. |
| Software used
for ordering
workflow | 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).