Ortho Aligner System

K212496 · Ortho Lab Services, LLC · NXC · Nov 4, 2021 · Dental

Device Facts

• Record ID: K212496
• Device Name: Ortho Aligner System
• Applicant: Ortho Lab Services, LLC
• Product Code: NXC · Dental
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Ortho Aligner System consists of series of clear, thin, thermoformed removable PET-G aligner trays; designed to correct tooth malocclusions without conventional wires/brackets. Process: dental practitioner provides physical impressions or digital intraoral scans; Ortho Lab Services uses OrthoWare software to create 3D treatment plan; practitioner approves plan via OrthoPortal and issues electronic prescription; aligners manufactured via thermoforming on models. Trays worn by patient as prescribed; removed by patient as needed. Each tray applies continuous gentle force to reposition teeth in sequence until realignment goal met. Used in clinical/dental setting under practitioner guidance. Benefits: customized orthodontic correction.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5 (cytotoxicity), and -10 (sensitization/irritation) on raw material and finished aligners; all passed. Software verification and validation confirmed adherence to specifications. Manufacturing process validation confirmed accuracy of final thermoformed aligner compared to initial digital scans. No animal or human clinical data required.

Technological Characteristics

Material: PET-G thermoplastic sheet. Design: 3D modeling software (OrthoWare). Manufacturing: Thermoforming on models. Energy: None (passive mechanical force). Connectivity: Not specified. Sterilization: Non-sterile. Software: Treatment planning and design.

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

• Smart Moves Complete, Great Lakes Orthodontics, Ltd. (K172765)

Submission Summary (Full Text)

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November 4, 2021

Ortho Lab Services, LLC % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K212496

Trade/Device Name: Ortho Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 6, 2021 Received: August 9, 2021

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.

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

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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/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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. 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) K212496

Device Name

Ortho Aligner System

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) SUMMARY – K212496

| SUBMITTER | |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Ortho Lab Services, LLC |
| Submitter Address: | 251 Little Falls<br>Wilmington, DE 19808 |
| Contact Person:<br>Telephone: | Zuzana Huelsbusch, Regulatory Director<br>0049-1573-0655-886 |
| Date Prepared: | October 28, 2021 |
| DEVICE | |
| Device Trade Name: | Ortho Aligner System |
| Common Name: | Aligner, Sequential (Clear Braces) |
| Classification Name<br>Number<br>Product Code<br>Regulatory Class | Orthodontic Plastic Bracket<br>21 CFR 872.5470<br>NXC<br>2 |
| Review Panel | Dental |
| PREDICATE DEVICE | K172765, Smart Moves Complete, Great Lakes Orthodontics,<br>Ltd. |
| INDICATIONS FOR<br>USE STATEMENT | The Ortho Aligner System is indicated for the treatment of tooth<br>malocclusion in patients with permanent dentition (i.e. all<br>second molars). The Ortho Aligner System positions teeth by<br>way of continuous gentle force. |
| DEVICE<br>DESCRIPTION | The Ortho Aligner System is comprised of a series of clear,<br>thin, thermoformed removable aligner trays that are designed to<br>correct tooth malocclusions without the use of conventional<br>wire and bracket orthodontic technology. The aligners are<br>provided non-sterile and are customized for each patient<br>according to the dental practitioner's prescription. |
| | Physical impressions or digital intraoral scans of the patient's<br>teeth are provided to Ortho Lab Services. A treatment plan<br>consisting of 3D models is created from the impressions or<br>scans, by Ortho Lab Services using the OrthoWare software.<br>Upon approval of the treatment plan by the treating dental<br>practitioner using OrthoPortal and issuance of an electronic<br>prescription, the clear aligners are manufactured using<br>thermoforming methods. |
| | The finished, customized aligners are shipped based on the<br>dental practitioner's order and confirmed for patient fit and<br>design. |
| | The aligner trays are held in place by pressure and can be<br>removed by the patient at any time. |
| MECHANISM OF<br>ACTION | Each aligner in sequence applies the pressure (continuous<br>force) on the teeth targeted to be repositioned in that step.<br>Once the prescribed treatment period is concluded, the next set<br>of aligner trays is used; this continues until the realignment goal<br>has been met. The patient wears the thermoformed aligners for<br>the prescribed time in sequence, as monitored and guided by<br>the clinical/dental practitioner. |
| SUMMARY OF<br>TECHNOLOGICAL<br>CHARACTERISTICS | Materials<br>The thermoplastic materials used for the manufacture of the<br>Ortho Aligners is the same material type which is used to make<br>the Predicate Smart Moves Complete aligners, a PET-G<br>thermoplastic sheet.<br><br>Design<br>The subject aligners are designed using similar methods and<br>similar design software as the Predicate. Ortho Lab Services<br>uses their OrthoWare software, which is similar to the Predicate<br>manufacturer's Smart Moves Complete 3-D software.<br><br>Manufacturing Process<br>The process used to manufacture the Ortho Aligner System is<br>thermoforming the material on a model (or mold), the same<br>process method as used by the Predicate device manufacturer. |
| SAFETY TESTING | Biocompatibility: Testing of the plastic thermoformable material<br>was performed for the material supplier by a contract test<br>laboratory according to Good Laboratory Practices and to meet<br>the requirements of ISO 10993-1 and Part 5 (Cytotoxicity) and<br>Part 10 (Sensitization).<br><br>In addition to the material biocompatibility, the submitter<br>contracted to have testing performed according to ISO 10993-5<br>(Cytotoxicity) of the finished thermoformed aligner.<br><br>All biocompatibility testing passed the test requirements. |
| PERFORMANCE<br>TESTING | Software Verification and Validation Testing<br>Software V & V testing, using FDA's guidance document,<br>confirmed acceptance to required specifications.<br><br>Bench testing<br>Testing to validate the manufacturing process was performed.<br>The test results ensured the accuracy of the final thermoformed<br>aligner compared to the initial digital scans. Aligners met the<br>specifications of the testing.<br><br>In vivo Animal and Human Clinical<br>Animal and human performance testing are not required for this<br>device category. |
| COMPARISON TO<br>THE PREDICATE<br>DEVICE | The Ortho Aligner System has the same intended use as the predicate device. |
| | There are no fundamental technological differences between the subject and Predicate device. The differences, listed below, do not raise new types of safety and effectiveness questions:<br>• The materials are of the same type: biocompatible PET-G sheets, developed for use by dental device manufacturers for fabricating customized dental appliances, including aligners. |
| | • The software products used for design of the subject and Predicate devices are different, but have the same purpose and are used in a similar way to design the treatment plans for tooth movement. They both use digital scans to generate images of the final treated states, and intermediate steps to achieve the final state, and convert those files to produce the series of customized aligners. |
| | • The manufacturing process methods are different but similar: both use standard methods and equipment to thermoform the designed aligners. |
| CONCLUSION | The conclusions drawn from the side-by-side comparison and the nonclinical testing presented in the 510(k), demonstrate that the subject Ortho Aligner System is as safe and effective, and thus substantially equivalent to, the legally-marketed Smart Moves Complete Predicate. |

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## Substantial Equivalence Comparison Table

| | Subject Device | Predicate Device<br>K172765 | Comparison |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device Name | Ortho Aligner System | Smart Moves Complete | N/A |
| Manufacturer | Ortho Lab Services, LLC | Great Lakes Orthodontics Ltd | N/A |
| Classification<br>Regulation #<br>and Name<br>Product Code<br>Class | 21 CFR 872.5470<br>Orthodontic Plastic Bracket<br>NXC<br>2 | 21 CFR 872.5470<br>Orthodontic Plastic Bracket<br>NXC<br>2 | Same |
| Indications for<br>Use | The Ortho Aligner 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 Ortho Aligner<br>System positions teeth by<br>way of continuous gentle<br>force. | Smart Moves Complete is<br>indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition (i.e.<br>all second molars). Smart<br>Moves Complete positions<br>teeth by way of continuous<br>gentle force. | Same |
| Mode of Action | The appliance applies gentle<br>forces on teeth according to<br>the plan prescribed by the<br>doctor. | The appliance applies gentle<br>forces on teeth according to<br>the plan prescribed by the<br>doctor. | Same |
| Description of<br>Use | Each removable preformed<br>plastic tray is worn by the<br>patient as prescribed by the<br>doctor, usually a few weeks<br>prior to using the next<br>sequential aligner tray. | Each removable preformed<br>plastic tray is worn by the<br>patient as prescribed by the<br>doctor, usually a few weeks<br>prior to using the next<br>sequential aligner tray. | Same |
| Material | Thermoplastic PETG | Thermoplastic PETG | Same material type |
| Manufacturing<br>Process | Thermoforming on models | Thermoforming on models | Same process,<br>similar methods |
| Software Used | Yes, for treatment planning<br>and design of sequential<br>trays by Ortho Lab Services. | Yes, for treatment planning<br>and design of sequential<br>trays. | Same purposes;<br>Similar software |
| Prescription<br>Use | Rx | Rx | Same |
| Single Patient<br>Use | Yes | Yes | Same |
| Biocompatibility | Meets ISO 10993-1, -5, -10<br>requirements: Cytotoxicity<br>and Sensitization/Irritation | Meets ISO 10993-1, -5, -10<br>requirements: Cytotoxicity<br>and Sensitization/Irritation | Same |
| Process Flow<br>Validation<br>Testing | Performed testing to validate<br>the finished device matches<br>the software output design. | Performed testing to validate<br>the finished device matches<br>the software output design. | Same |