TP Orthodontics Clear Aligner System

K193385 · Tp Orthodontics, Inc. · NXC · Nov 12, 2020 · Dental

Device Facts

• Record ID: K193385
• Device Name: TP Orthodontics Clear Aligner System
• Applicant: Tp Orthodontics, Inc.
• Product Code: NXC · Dental
• Decision Date: Nov 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

Device Story

Custom-made series of thermoplastic aligners; used for orthodontic tooth movement. Clinician takes dental impressions; submits to manufacturer with prescription. Manufacturer uses standard dental software to design incremental tooth movement stages; physician reviews and approves digital model scheme. Aligners produced via thermoplastic material; shipped to practitioner. Patient wears aligners 20-22 hours/day; replaces every 2-3 weeks per prescription. Clinician monitors case progression, fit, and function through follow-up appointments. Continuous gentle force applied to teeth to achieve alignment.

Clinical Evidence

No clinical testing performed. Substantial equivalence is supported by established performance of the sequential aligner category and manufacturing validation demonstrating dimensional accuracy against software output specifications.

Technological Characteristics

Custom-made thermoplastic aligners (co-polyester or co-polymer). Principle of operation: continuous gentle force for orthodontic tooth movement. Software-driven design workflow. Biocompatibility established via reference to previously cleared material (K062828).

Indications for Use

Indicated for treatment of tooth malocclusions 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

• 3M Clear Tray Aligner (K163689)

Reference Devices

• Ortho System (K180941)
• Mouthguard and Aligner Material (K062828)
• MTM Clear Aligner (K163155)

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 & 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.

November 12, 2020

TP Orthodontics Inc. Stephanie Thyen QA/RA Manager 100 Center Plaza La Porte, Indiana 46350-9672

Re: K193385

Trade/Device Name: TP Orthodontics Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 24, 2020 Received: October 5, 2020

# Dear Stephanie Thyen:

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

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

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 Srinivas "Nandu" Nandkumar, Ph.D. 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

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

# Indications for Use

510(k) Number (if known) K193385

#### Device Name

TP Orthodontics Clear Aligner System

#### Indications for Use (Describe)

TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially 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) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

#### 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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a blue globe with an arrow wrapping around it on the left side. To the right of the globe is the text "TP Orthodontics, Inc." in a simple, sans-serif font.

# K193385

November 20, 2019

# 510(k) Summary

# Submitter Information:

TP Orthodontics, Inc. 100 Center Plaza, La Porte, IN Contact Person: Cristiane Muller Phone Number: 1.800.348.8856 / 219.785.2591 Fax: [phone] E-mail: [e-mail]

# Device Information:

Trade Name: TP Orthodontics Clear Aligner System Common Name: Aligners, Sequential Product Code: NXC Classification Name: Orthodontic Plastic Bracket Regulation Number: 872-5470 Device Class: II Classification Panel: Dental

# Predicate Devices:

| Device | Applicant | 510(k) Number |
|-----------------------|-----------------------|---------------|
| 3M Clear Tray Aligner | 3M Unitek Corporation | K163689 |

# Reference Predicate Devices:

| Device | Applicant | 510(k) Number |
|------------------------------------|------------------------|---------------|
| Ortho System | 3Shape A/S | K180941 |
| Mouthguard and Aligner<br>Material | Dentsply International | K062828 |
| MTM Clear Aligner | Dentsply Sirona | K163155 |

# Indications for Use:

TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

# Device Description and Summary of Technological Characteristics:

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment.

A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription.

TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor

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

has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner.

The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.

Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

| Characteristic | TP Orthodontics<br>Clear Aligner<br>System<br>Proposed Device | 3M Clear Tray<br>Aligner<br>Primary Predicate | MTM Clear Aligner<br>Reference<br>Predicate | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | To be determined | K163689 | K163155 | N/A |
| Manufacturer | TP Orthodontics,<br>Inc. | 3M Unitek<br>Corporation | Dentsply Sirona/<br>Raintree Essix Inc. | N/A |
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Device | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Same |
| Classification Name | Orthodontic Plastic<br>Bracket | NXC | NXC | Same |
| Product Code | NXC | NXC | NXC | Same |
| Device Class | Class II | Class II | Class II | Same |
| Indications for Use | TP Orthodontics<br>Clear Aligner<br>System consists of a<br>series of plastic<br>appliances indicated<br>for the treatment of<br>tooth malocclusions<br>in patients with<br>permanent dentition<br>(i.e. all second<br>molars). Utilizing a<br>series of<br>incremental tooth<br>movements, TP<br>Orthodontics Clear<br>Aligner System<br>sequentially<br>positions teeth by<br>way of continuous<br>gentle force. | The 3M Clear Tray<br>Aligner System is a<br>series of clear,<br>lightweight, plastic<br>appliances indicated<br>for the treatment of<br>tooth malocclusions<br>in patients with<br>permanent dentition<br>(i.e. all second<br>molars). Utilizing a<br>series of incremental<br>tooth movements, it<br>sequentially positions<br>teeth by way of<br>continuous gentle<br>force. | MTM® Clear Aligner<br>is indicated for the<br>treatment of anterior<br>tooth malocclusions<br>in patients with<br>permanent dentition<br>(i.e. all second<br>molars). Utilizing a<br>series of<br>incremental minor<br>tooth movements,<br>MTM® Clear Aligner<br>sequentially<br>positions teeth by<br>way of continuous<br>gentle force. | Similar. The<br>verbiage of the<br>indications for use<br>is slightly different<br>than the primary<br>and reference<br>predicates,<br>however, these<br>slight differences in<br>wording do not<br>change the<br>intended use of the<br>subject device in<br>relation to the<br>predicate devices<br>and does not raise<br>any new questions<br>about safety and<br>effectiveness. |
| Intended Population | Individuals with<br>permanent dentition | Individuals with<br>permanent dentition | Individuals with<br>permanent dentition | Same |
| Material | Co-polyester or co-<br>polymer;<br>Thermoplastic | Thermoplastic | Co-polyester or co-<br>polymer;<br>Thermoplastic | Similar. All devices<br>are made of a<br>biocompatible<br>thermoplastic<br>material. |
| Mode of action | Continuous gentle<br>forces applied to<br>teeth to attain<br>orthodontic tooth<br>movement | Continuous gentle<br>forces applied to<br>teeth to attain<br>orthodontic tooth<br>movement | Continuous gentle<br>forces applied to<br>teeth to attain<br>orthodontic tooth<br>movement | Same |
| Characteristic | TP Orthodontics<br>Clear Aligner<br>System<br>Proposed Device | 3M Clear Tray<br>Aligner<br>Primary Predicate | MTM Clear Aligner<br>Reference<br>Predicate | Comparison |
| Method of Use | Aligners are worn by<br>the patient<br>according to the<br>treating doctor<br>prescription. | Aligners are worn by<br>the patient according<br>to the treating doctor<br>prescription. | Aligners are worn by<br>the patient<br>according to the<br>treating doctor<br>prescription. | Same |
| Software Used for<br>Ordering Workflow | Yes | Yes | Yes | Same |
| Prescription (Rx) or<br>Over-the-Counter<br>(OTC) | Rx | Rx | Rx | Same |
| Design of Aligners | Image: Clear aligner | Image: Clear aligner | Image: Clear aligner | Same. All are<br>comprised of clear<br>thermoplastic trays<br>that seat over the<br>teeth. |

#### Table 5.1. Substantial Equivalence Comparison

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

Image /page/5/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a stylized globe with blue lines and an arrow wrapping around it. To the right of the globe is the text "TP Orthodontics, Inc.", with "TP" in a slightly larger font size than the rest of the text.

# Clinical Performance Data

The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. TP Orthodontics Clear Aligner System have equivalent indication and method of use to its primary and reference predicate devices, therefore there was no clinical testing to support this device.

# Non-Clinical Performance Data

A manufacturing validation was performed to ensure the dimensional accuracy of TP Orthodontics Clear Aligner System and assess the integration between the steps of the manufacturing process. The validation demonstrated that the aligners manufactured match the software output specifications. Physical properties testing was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.

#### Biocompatibility Testing

Biocompatibility tests were not performed as TP Orthodontics Clear Aligner System are made of the same material (thermoplastic material) as its primary and reference predicate devices. The material used (Aligner Material from Dentsply, 510(k) K062828) is the same used in the fabrication of MTM aligners (reference predicate device), and therefore there are no differences in biocompatibility between them. Biocompatibility testing data was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.

#### Software Verification and Validation Testing

Both software used with TP Orthodontics Clear Aligner System passed their validations.

#### Substantial Equivalence Conclusion

TP Orthodontics Clear Aligner System presents substantially equivalent indication for use and technological characteristics as its primary and reference predicate devices. There are slight differences in the language of the indications for use, however these differences do not impact safety and efficacy of the device.

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

Image /page/6/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a blue globe with an arrow wrapping around it. The text "TP Orthodontics, Inc." is written in a simple, sans-serif font to the right of the globe. The logo is clean and professional, and the blue color gives it a sense of trustworthiness.

It is concluded that TP Orthodontics Clear Aligner System is safe, effective, and substantially equivalent to its primary and reference predicate devices.