Byte Aligner System

K180346 · Straight Smile, LLC · NXC · Feb 19, 2019 · Dental

Device Facts

• Record ID: K180346
• Device Name: Byte Aligner System
• Applicant: Straight Smile, LLC
• Product Code: NXC · Dental
• Decision Date: Feb 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Byte Aligner System consists of series of clear, thermoformed PETG plastic aligners; designed to progressively reposition teeth via continuous gentle force. Device used in oral cavity; patient wears each aligner in sequence for approximately two weeks as prescribed by dental practitioner. Aligners fabricated based on dental practitioner's prescription and design software. System functions by applying pressure to dentition to achieve programmed displacement. Benefits include correction of tooth malocclusion.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization) per ISO 10993. Manufacturing process validation performed. 2-year shelf life validated via real-time testing.

Technological Characteristics

Material: Polyethylene terephthalate glycol (PETG). Form factor: Series of clear, thermoformed, removable aligners. Mechanism: Continuous gentle force via programmed displacement. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

• ClearCorrect System (K113618)

Reference Devices

• Smart Moves Complete (K172765)

Submission Summary (Full Text)

{0}------------------------------------------------

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

Straight Smile, LLC % Craig Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman St Alameda, California 94501

February 19, 2019

Re: K180346

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: November 24, 2018 Received: November 26, 2018

### Dear Craig Coombs:

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 (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 located 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}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.02.19
19:02:26 -05'00'

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K180346

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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## K180346: 510(k) Summary

## A. Device Information:

| Category | Comments |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Straight Smile, LLC; dba: Byte<br>370 Alabama St., Ste K<br>Redlands, California 92373<br>Office phone: [phone]<br>Fax Number: 1.512.727.0429<br>E-mail: [e-mail]<br>Contact: Sepi Abbasi, Managing Member |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Sequential Aligners |
| Device Classification Number: | 21 CFR 872.5470 |
| Device Classification &<br>Product Code: | Class II,<br>NXC |
| Device Proprietary Name: | Byte Aligner System |

## Predicate Device Information:

| Predicate Device: | ClearCorrect System |
|-------------------------------------------|---------------------|
| Predicate Device Manufacturer: | ClearCorrect, Inc |
| Predicate Device Common Name: | Sequential Aligners |
| Predicate Device Premarket Notification # | K113618 |
| Predicate Device Classification: | 21 CFR 872.5470 |
| Predicate Device Classification & | Class 2, |
| Product Code: | NXC |

## Reference Device Information:

| Reference Device: | Smart Moves Complete |
|----------------------------------------------------|------------------------------|
| Reference Device Manufacturer: | Great Lakes Orthodontics Ltd |
| Reference Device Common Name: | Sequential Aligners |
| Reference Device Premarket Notification # | K172765 |
| Reference Device Classification: | 21 CFR 872.5470 |
| Reference Device Classification &<br>Product Code: | Class 2, |
| | NXC |

## B. Date Summary Prepared

11 February 2019

{4}------------------------------------------------

## C. Description of Device

The Byte Aligner System is a series of Byte dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

## D. 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.

## E. Comparison to Predicate/Reference Devices

The Straight Smile Byte Aligner System is substantially equivalent in intended use, indications for use, mode of action, mode of use, design and materials to the predicate ClearCorrect System (K113618).

Both devices have identical Indications for Use, except for the device name, which implies they have the same intended use.

Both devices have the same modes of action and use. Both are a sequential series of rigid aligners that gently pressure the teeth to move in a desired manner. The patient transitions to the next aligner in the series approximately every two weeks. After completing the series, the user's teeth should conform to the desired position.

The application and predicate aligners are made from different base materials. The predicate aligners are made from thermoplastic polyurethane. The Byte aligners are made from thermoplastic PETG. PETG has been used in other dental appliances and aligners, including the reference device Smart Moves Complete sequential aligners (K172765). Straight Smile conducted testing that demonstrated that the PETG material can be manufactured into aligners and meet the same safety and performance criteria as the predicate and reference devices.

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

Straight Smile concludes that the predicate ClearCorrect System (K113618) and the application Byte Aligner System are substantially equivalent.

{5}------------------------------------------------

## Substantial Equivalence Justification Table

| | PREDICATE DEVICE<br>ClearCorrect System<br>ClearCorrect, Inc.<br>K113618 | REFERENCE DEVICE<br>Smart Moves Complete<br>Great Lakes Orthodontics Ltd<br>K172765 | APPLICATION DEVICE<br>Byte System<br>Straight Smile, LLC | Substantial Equivalence<br>Analysis |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Common Name | Sequential Aligner | Sequential Aligner | Sequential Aligner | Identical to both predicate<br>and reference devices |
| Classification # | 872.5470 | 872.5470 | 872.5470 | Identical to both |
| Product Code | NXC | NXC | NXC | Identical to both |
| Indication for Use | The ClearCorrect System is<br>indicated for the treatment of<br>tooth malocclusion in<br>patients with permanent<br>dentition (i.e. all second<br>molars), The ClearCorrect<br>System positions teeth by<br>way of continuous gentle<br>force. | Smart Moves Complete is<br>indicated for the treatment<br>of tooth malocclusion in<br>patients with permanent<br>dentition (i.e. all second<br>molars). Smart Moves<br>Complete positions teeth by<br>way of continuous gentle<br>force. | The Byte Aligner System is<br>indicated for the treatment<br>of tooth malocclusion in<br>patients with permanent<br>dentition (i.e., all second<br>molars). The Byte Aligner<br>System positions teeth by<br>way of continuous gentle<br>force. | Identical to both, except<br>for device name |
| Intended Population | Individuals with permanent<br>dentition | Individuals with permanent<br>dentition | Individuals with permanent<br>dentition | Identical to both |
| Mode of Action | Orthodontic tooth movement<br>occurs through forces applied<br>by the device to the dentition<br>as each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription. | Orthodontic tooth<br>movement occurs through<br>forces applied by the device<br>to the dentition as each<br>tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription. | Orthodontic tooth<br>movement occurs through<br>forces applied by the device<br>to the dentition as each<br>tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription. | Identical to both |
| Anatomical Site of Use | Oral cavity | Oral cavity | Oral cavity | Identical to both |

{6}------------------------------------------------

510(k) Summary K180346: Byte Aligner System

| | PREDICATE DEVICE<br>ClearCorrect System<br>ClearCorrect, Inc.<br>K113618 | REFERENCE DEVICE<br>Smart Moves Complete<br>Great Lakes Orthodontics Ltd<br>K172765 | APPLICATION DEVICE<br>Byte System<br>Straight Smile, LLC | Substantial Equivalence<br>Analysis |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Mode of Use | Each aligner is worn by the<br>patient as determined by the<br>treating dental practitioner,<br>generally for 2 weeks prior to<br>being replaced by the next<br>aligner in sequence. This is<br>repeated for a duration as<br>prescribed by a Dental<br>Professional. | Each aligner is worn by the<br>patient as determined by the<br>treating dental practitioner,<br>generally for 2 weeks prior to<br>being replaced by the next<br>aligner in sequence. This is<br>repeated for a duration as<br>prescribed by a Dental<br>Professional. | Each aligner is worn by the<br>patient as determined by the<br>treating dental practitioner,<br>generally for 2 weeks prior to<br>being replaced by the next<br>aligner in sequence. This is<br>repeated for a duration as<br>prescribed by a Dental<br>Professional. | Identical to both |
| Application | Removable | Removable | Removable | Identical to both |
| Raw Material Used | Thermoplastic polymers<br>(polyurathane) | Thermoplastic polymers<br>(polyethylene terephthalate<br>glycol or PETG) | Thermoplastic polymers<br>(polyethylene terephthalate<br>glycol or PETG) | Identical to Reference<br>device. Used in same way. |
| OTC or Rx | Rx | Rx | Rx | Identical to both |
| Design | Image: ClearCorrect aligner | Image: Smart moves complete aligner | Image: Byte System aligner | Design is developed and<br>fabricated by similar or<br>identical processes used by<br>predicate and reference<br>devices |

{7}------------------------------------------------

#### F. Summary of Supporting Data

Biocompatibility analysis demonstrates that the Byte Aligner System is in compliance with ISO 10993. Testing included:

Cytotoxicity

Sensitization

Information was provided to demonstrate that PETG is commonly used for dental appliances and in other aligners.

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling.

Straight Smile validated the manufacturing process of the Byte aligners, demonstrating that the process can adequately render the final device as specified by appropriate FDA-cleared design software.

Straight Smile validated the 2-year shelf life of the aligners with real-time testing.

### G. Conclusion

The Byte Aligner System is substantially equivalent to the predicate device (ClearCorrect System: K113618) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.