SureCure Orthodontic Aligner System

K182329 · Digital Orthodontic Care · NXC · Nov 8, 2018 · Dental

Device Facts

• Record ID: K182329
• Device Name: SureCure Orthodontic Aligner System
• Applicant: Digital Orthodontic Care
• Product Code: NXC · Dental
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SureCure Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

Device Story

SureCure Orthodontic Aligner System consists of series of customized clear plastic removable aligners; fabricated from thin thermoformed polyurethane. Inputs: standard dental impressions or intraoral scans provided by prescribing dentist/orthodontist. Process: manufacturer creates physical models from impressions; models scanned using validated software; digital files used to 3D print molds; aligners thermoformed over molds. Output: series of sequential aligners. Usage: patient wears aligners as prescribed by clinician; aligners exert continuous gentle force to incrementally reposition teeth. Benefit: progressive realignment of teeth to correct malocclusion.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity (MEM Elution). Shelf-life testing validated for 5 years. No animal or human clinical testing required due to material and design equivalence to predicate.

Technological Characteristics

Material: thermoformed polyurethane. Form factor: series of customized clear removable aligners. Manufacturing: 3D printed models based on digital scans/impressions, followed by thermoforming. Connectivity: software-based digital workflow. Sterilization: non-sterile.

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition.

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

• Ortho Analyzer (K152086)

Submission Summary (Full Text)

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

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 and 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.

Digital Orthodontic Care % Patsy Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815

Re: K182329

Trade/Device Name: SureCure Orthodontic Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 2, 2018 Received: November 2, 2018

Dear Patsy Trisler:

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.

November 8, 2018

{1}------------------------------------------------

ence determination does not mean that FDA

Page 2

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 -S33 Date: 2018.11.08 08:47:46 -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) K182329

Device Name

SureCure Orthodontic Aligner System

#### Indications for Use (Describe)

The Sure Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

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

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> 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}------------------------------------------------

## K182329

# 510(k) Summary

| Submitter Name: | Digital Orthodontic Care |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 348 Bronte Street, Unit 16<br>Milton, ON L9T 5B6 CANADA |
| Phone Number: | 647-977-7253 |
| Contact Person: | Mr. Jeff Sheppard<br>President |
| Date Prepared: | November 7, 2018 |
| Device Trade Name: | SureCure Orthodontic Aligner System |
| Common Name | Aligner, Sequential |
| Classification Name<br>Number<br>Product Code<br>Regulatory Class | Orthodontic Plastic Bracket<br>21 CFR 872.5470<br>NXC<br>2 |
| Primary Predicate<br>Device: | K113618, ClearCorrect System, ClearCorrect, LLC |
| Reference Device: | K152086, Ortho Analyzer, 3Shape A/S |
| Statement of<br>Intended Use | The SureCure Orthodontic Aligner System is indicated for the<br>treatment of tooth malocclusion in patients with permanent<br>dentition. The aligner system repositions teeth by way of<br>continuous gentle force. |
| Device Description<br>and Summary of<br>Technological<br>Characteristics | Digital Orthodontic Care's SureCure Orthodontic Aligner System<br>consists of a series of customized clear plastic removable aligners<br>that are fabricated from a clear, thin thermoformed polyurethane.<br>The aligners are designed to gradually move the patient's teeth<br>incrementally, repositioning them from their original misalignment<br>to a more aligned state. |
| | Digital Orthodontic Care manufactures the customized aligners<br>based on either standard impressions or intraoral scans sent to<br>the company by the prescribing dentist or orthodontist.<br>Digital Orthodontic Care manufactures models from the<br>impressions and those models are scanned using standard<br>validated software. The digital files are used to produce the<br>aligner series with the thermoplastic polyurethane. |
| | The thermoplastic material used for fabrication of the aligners is<br>commonly used in many dental appliances, including the<br>predicate aligners. |
| Mechanism of Action Based on the clinician's treatment plan, each aligner is used for a | defined period of time to exert gentle force to achieve progressive |
| correction has been achieved. | realignment of the teeth. This occurs over time until the final |
| | |

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

Device Testing Laboratory Testing

> Test data were submitted to validate the processes used for the design and manufacture of the aligners.

### Biocompatibility

The thermoplastic polyurethane used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993. In addition, the final finished aligner device was tested according to ISO 10993, Part 5 (Cytotoxicity - MEM Elution).

The testing has shown that the material is safe and biocompatible for the stated intended use.

### Shelf-life Testing

The aligner material has been tested after real-time storage for a shelf life of 5 years.

Animal | Human Testing

Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device.

Comparison to A side-by-side comparison of SureCure to the predicate device is Predicate Device: presented in the Substantial Equivalence Comparison table.

Based on the documentation presented in the 510(k), as Substantial Equivalence summarized above and in the following table, it can be concluded Conclusion that Digital Orthodontic Care's SureCure Orthodontic Aligner System is substantially equivalent to the predicate device.

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

| Trade Name: | SureCure Orthodontic | ClearCorrect System |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aligner System | |
| 510(k) Number | K182329 | K113618 |
| Manufacturer | Digital Orthodontic Care | ClearCorrect, LLC |
| Classification # &<br>Product Code<br>Class | 21 CFR 852.5470<br>NXC<br>2 | 21 CFR 852.5470<br>NXC<br>2 |
| Intended Use | The SureCure Orthodontic<br>Aligner System is indicated for<br>the treatment of tooth<br>malocclusion in patients with<br>permanent dentition. The<br>aligner system repositions teeth<br>by way of continuous gentle<br>force. | The ClearCorrect System is<br>indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition (i.e. all<br>second molars). The Clear<br>Correct System positions teeth<br>by way of continuous gentle<br>force. |
| Mode of Action | Alignment of teeth by<br>application of continuous gentle<br>force, by sequential use of<br>preformed plastic trays. | Alignment of teeth by<br>application of continuous gentle<br>force, by sequential use of<br>preformed plastic trays. |
| Method of Use | Each preformed plastic tray is<br>worn by the patient as<br>prescribed by the dental<br>practitioner, usually a few<br>weeks prior to using the next<br>sequential aligner tray. | Each preformed plastic tray is<br>worn by the patient as<br>prescribed by the dental<br>practitioner, usually a few<br>weeks prior to using the next<br>sequential aligner tray. |
| Material | Thin thermoformed<br>polyurethane | Thin thermoformed<br>polyurethane |
| Method of<br>Manufacture | Using software, molds/models<br>are 3D printed based on the<br>treatment plan. Aligners are<br>fabricated on the molds using a<br>thermoforming machine. | Using software, molds/models<br>are 3D printed based on the<br>treatment plan. Aligners are<br>fabricated on the molds using a<br>thermoforming machine. |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |

## Substantial Equivalence Comparison