Archworx

K173738 · Utah Medical Products and Services · NXC · Feb 26, 2021 · Dental

Device Facts

• Record ID: K173738
• Device Name: Archworx
• Applicant: Utah Medical Products and Services
• Product Code: NXC · Dental
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Archworx are a series of sequential aligner trays used to treat malocclusion in patients with full, permanent dentition by way of continuous gentle force; used under the direction of a Prescribing Dentist or Orthodontist.

Device Story

Archworx consists of sequential thermoformed plastic aligner trays for orthodontic tooth movement. Input data includes patient intraoral scans or impressions provided by a dentist/orthodontist. The clinician performs a clinical assessment and designs a treatment plan using 3Shape Ortho System Software (Appliance Designer and Ortho Analyzer). The manufacturer uses these digital files to 3D print models, over which Zendura FLX polycarbonate disks are thermoformed. The resulting aligners are inspected, cleaned, and trimmed. The device is used in a clinical setting under the supervision of a dentist or orthodontist, who dispenses the aligners in sequential stages. The aligners apply continuous gentle force to move teeth incrementally toward a final aligned position. The patient wears the aligners to achieve the prescribed tooth alignment, benefiting from a customized, removable orthodontic treatment.

Clinical Evidence

No clinical data. Evidence consists of bench performance testing and verification/validation. Biocompatibility testing (cytotoxicity, sensitization, irritation, oral mucosal irritation) per ISO 10993 met all acceptance criteria. Physical properties testing met pre-specified criteria. Verification/validation involved 3 patient cases where aligners were evaluated at 3 sequence points; 3 critical dimensions were measured per point to confirm the aligner matched the planned software design and prescribed tooth positions.

Technological Characteristics

Thermoformed polycarbonate (Zendura FLX). Sequential aligner trays. Biocompatibility per ISO 10993. Software-driven design using 3Shape Ortho System. Non-sterile, single-patient use. Permanent duration contact (>30 days).

Indications for Use

Indicated for the treatment of tooth malocclusion in patients with full, permanent dentition (i.e., 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

• Argen Clear Aligner and Argen Clear Aligner Premium (K192846)

Reference Devices

• 3Shape Ortho System Software (K180941)

Submission Summary (Full Text)

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February 26, 2021

Utah Medical Products and Services Brandon Farley Business Owner and President DBA Cottonwood Laboratories 6526 South State Street Suite #301 Murray, Utah 84107

Re: K173738

Trade/Device Name: Archworx Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 14, 2021 Received: January 19, 2021

Dear Brandon Farley:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental 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) K173738

Device Name Archworx

Indications for Use (Describe)

Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

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

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Image /page/3/Picture/0 description: The image shows the logo for Cottonwood Laboratories. The logo features a stylized drawing of a human face in profile, with the brain highlighted in red. Next to the drawing is the company name, "Cottonwood LABORATORIES," with "LABORATORIES" in smaller font. Below the name is the company website address, "www.cottonwoodortholab.com."

| Manufacturer Name/Submitter | Utah Medical Products and Services<br>(DBA Cottonwood Laboratories) | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Brandon Farley | |
| Phone Number and Address | [phone]<br>6526 State Street<br>Murray, UT 84107 | |
| Device Name | Archworx | |
| 510K Number | K17378 | |
| Device Classification Name | Orthodontic Plastic Brackets (Sequential Aligners) | |
| Regulation Number | 21 CFR 872.5470 | |
| Product Classification Code | NXC | |
| Product Class | 2 | |
| Review Panel | Dental | |
| Prescription or Over the Counter | Prescription | |
| Supplied Sterile | No | |
| Single Patient Use | Yes | |
| Physical Properties/Image | | |
| Concise Description | Devices are intraoral thermoformed plastic aligner trays for<br>tooth malocclusion correction. | |
| Indications for Use Statement | Archworx is indicated for the treatment of tooth<br>malocclusion in patients with full, permanent dentition (i.e.,<br>all second molars). Archworx is intended to position teeth<br>by way of continuous gentle force. | |
| Intended Use | Archworx are a series of sequential aligner trays used to<br>treat malocclusion in patients with full, permanent<br>dentition by way of continuous gentle force; used under the<br>direction of a Prescribing Dentist or Orthodontist. | |
| Device Duration | Permanent Duration Contact (Greater Than 30-Days) | |
| Schedule of Use | Aligners are used in a sequence with each aligner allowing<br>for tooth movement by using a gentle continuous force to<br>the final, aligned tooth position. | |
| Mechanism of Action | Prescribing Dentist or Orthodontist approved customized<br>appliances that move teeth in small increments from their<br>original misaligned and malposed state to a final aligned<br>state. | |
| Method of Fabrication | Aligners are manufactured based on impressions or scans<br>sent to the manufacturer by the Prescribing Dentist or<br>Orthodontist after the Prescribing Dentist or Orthodontist;<br>or clinician has performed a clinical assessment of the<br>patient's teeth, taken intraoral scans or impressions of the<br>patients teeth and designed a treatment plan. | |
| Method of Treatment | Prior to the start of the aligner manufacturing process and<br>printing the 3D Models, the lab formulates the aligner<br>treatment plan which is sent to the Prescribing Dentist or<br>Orthodontist for review and approval and that only after<br>approval of the treatment plan is the fabrication process<br>started. | |
| Software Used | Models are fabricated after the impressions which are then<br>scanned using the 3Shape Ortho System Software<br>(K180941); and the applications used are the Appliance<br>Designer and the Ortho Analyzer. | |
| Material of Fabrication | Thermoformed Polycarbonate (Plastic) - Digital files are<br>used to produce the aligners series using Zendura FLX. | |
| Fabrication | Plastic disk is thermoformed over the model, then aligners<br>are inspected, cleaned and trimmed. | |
| Distribution | Aligners are sent directly to the Prescribing Dentist or<br>Orthodontist for dispensing to patience in sequential stages<br>where the Prescribing Dentist or Orthodontist monitors the<br>patient throughout the entire treatment process. | |
| Biocompatibility | Biocompatibility testing was conducted by the material<br>manufacturer for cytotoxicity, sensitization, irritation, and<br>oral mucosal irritation according to the ISO 10993 | |
| | | standards and that the device met the acceptance criteria<br>for all tests. |
| | Bench Performance Testing | Physical properties testing was conducted, and testing<br>information was obtained from the material manufacturer.<br>All the physical properties testing met the pre-specified<br>acceptance criteria. |
| | Verification and Validation Testing | Yes, Performed. For 3 different patient cases, aligners were<br>evaluated at 3 different points through the sequence for<br>each sequence point, 3 critical dimensions based on<br>intended positions of these critical tooth structures. Testing<br>indicated the aligner designed in the software meets the<br>planned location, positions and all dimensions as expected;<br>and as prescribed. |
| | Primary Predicate | Argen Clear Aligner and Argen Clear Aligner Premium<br>(K192846) |
| | Reference Device | 3Shape Ortho System Software (K180941) |

Due to the updates within this submission, a 510K Summary Table is provided:

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Image /page/4/Picture/0 description: The image shows the logo for Cottonwood Laboratories. The logo features a stylized letter "C" in a dark blue color, with the words "ottonwood LABORATORIES" written to the right of the "C". Below the word "LABORATORIES" is the website address "www.cottonwoodortholab.com". To the left of the "C" is a red and gray graphic that appears to be an abstract design.

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Image /page/5/Picture/0 description: The image shows the logo for Cottonwood Laboratories. The logo features a stylized tree branch with red leaves on the left side. To the right of the branch is the company name, "Cottonwood LABORATORIES," in a combination of bold and regular fonts. Below the company name is the website address, "www.cottonwoodortholab.com."

## Conclusion

Comparison of the Proposed Device and the Primary Predicate Device demonstrate:

- Indications for Use ●
- Mechanism of Action ●
- Length, Duration, and Schedule of Use
- Design technology
- Material
- . Fabrication and composition

of Archworx, is substantially equivalent to the Primary Predicate Device; Argen Clear Aligner and Argen Clear Aligner Premium (K192846).