NEOLab Clear Aligners

K203339 · New England Ortho Lab, Inc. · NXC · Jan 6, 2021 · Dental

Device Facts

• Record ID: K203339
• Device Name: NEOLab Clear Aligners
• Applicant: New England Ortho Lab, Inc.
• Product Code: NXC · Dental
• Decision Date: Jan 6, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.

Device Story

NEOLab Clear Aligners are a series of customized, removable, clear thermoformed polyurethane-polyester resin trays; used for orthodontic tooth movement. Clinician submits dental scans and prescription to NEOLab; NEOLab plans treatment; clinician reviews and approves treatment plan; aligners fabricated and shipped to clinician. Patient wears aligners 22 hours/day; continuous gentle force incrementally repositions teeth to desired alignment. Used in dental clinic setting under supervision of dental practitioner. Benefits include correction of malocclusions via sequential appliance therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (Parts 3, 5, 10, 11), confirming non-cytotoxicity and safety. Mechanical property testing validated material specifications for a 5-year shelf life. No clinical data presented.

Technological Characteristics

Material: Thermoplastic polyurethane-polyester composite resin. Form factor: Customized, removable, clear thermoformed plastic trays. Energy source: None (mechanical force). Connectivity: Not specified. Sterilization: Non-sterile. Software: Used for treatment planning and fabrication.

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

• Ormco™ Spark™ Aligner System (K182826)

Reference Devices

• Ortho System™, 3Shape A/S (K152086)
• Ortho System™, 3Shape A/S (K180941)

Submission Summary (Full Text)

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January 6, 2021

New England Ortho Lab, Inc Olivia Channon Document Control Coordinator 3 Riverside Drive Andover, Massachusetts 01810

Re: K203339

Trade/Device Name: NEOLab Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 7, 2020 Received: December 7, 2020

Dear Olivia Channon:

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,

For Michael Adjodha 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) K192338

Device Name NEOLab Clear Aligners

Indications for Use (Describe)

NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.

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

| <div> <input checked="true" type="checkbox"/> <span> Residential Use (Part 21 CFR 601 Subpart E) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> <span> Over-The-Counter Use (21 CFR 601 </span> </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Premarket Notification: Special 510(k) Submitter: New England Ortho Lab, Inc (NEOLab) NEOLab Clear Aligners, K203339 NXC, Class II Dental

## Special 510(k) Summary

| Submitter Name | New England Ortho Lab, Inc |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address | 3 Riverside Dr<br>Andover, MA 01810 |
| Phone Number | +1 (800) 922 - 6365 |
| Contact Person | Ms. Olivia Channon<br>Document Control Coordinator<br>[e-mail] |
| Date Prepared | December 2, 2020 |
| Device Trade Name | NEOLab Clear Aligners |
| 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>II |
| Primary Predicate<br>Device | K182826, Ormco™ Spark™ Aligner System, Sybron Dental Specialties |
| Reference Devices | K152086, Ortho System™, 3Shape A/S<br>K180941, Ortho System™, 3Shape A/S |
| Statement of Intended<br>Use | NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in<br>patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners<br>position teeth through the use of continuous gentle force. |
| Device Description and<br>Summary of<br>Technological<br>Characteristics | NEOLab Clear Aligners consist of a series of customized clear plastic removable<br>aligners that are fabricated from a clear, thin thermoformed polyurethane-polyester<br>resin, and are intended to be worn 22 hours a day. The aligners are designed to<br>gradually move the patient's teeth incrementally, repositioning them from their<br>original misalignment to a more aligned state. |

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patient in sequential stage, and confirms fit and functions and monitors the patient through the entire course of aligner therapy. This summary of technological characteristics is unchanged from the predicate device.

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 realignment of the teeth. This occurs over time until the final correction has been achieved.

#### Device Testing Laboratory Testing

Test data were submitted to:

- Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life;
- Validate the processes used for the design and manufacture of the customized aligners.

### Biocompatibility

The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:

- Part 3 (Bacterial Mutagenicity Ames Assay) ●
- Part 5 (Cytotoxicity Elution - MEM)
- Part 10 (Intracutaneous/Intradermal Reactivity) ●
- Part 10 (Oral Mucosa Irritation)
- Part 10 (Maximization for Delayed-Type Hypersensitivity)
- Part 11 (Subacute Systemic Toxicity)

Further, the finished customized aligner was tested according to ISO 10993, Part 5, Cytotoxicity. Results show it is non-cytotoxic.

This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use.

There are no notable differences comparing the NEOLab Clear Aligner to the Ormco™ Comparison to Predicate Device Spark™ Aligner System predicate device:

- The intended use is the same; ●
- The mechanism of action is similar;
- The polyurethane-polyester material used to make the aligners is the same; ●
- The method of manufacture and customizing the aligners is similar;
- The use of software for planning and manufacture is similar.

Substantial Based on the documentation presented in this Special 510(k), as summarized above, it can be concluded that NEOLab Clear Aligners are substantially equivalent to the Equivalence Conclusion predicate device.

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| Trade Name | NEOLab Clear Aligners | Ormco™ Spark™ Aligner System |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K203339 | K182826 |
| Submission | Special 510(k) | Traditional 510(k) |
| Manufacturer | New England Ortho Lab, Inc | Sybron Dental Specialties |
| Classification No. | 21 CFR 852.5470 | 21 CFR 852.5470 |
| Product Code | NXC | NXC |
| Class | II | II |
| Indications for Use | NEOLab Clear Aligners are indicated for<br>the treatment of tooth malocclusion in<br>patients with permanent dentition (i.e.<br>all second molars). The NEOLab Clear<br>Aligners position teeth by way of<br>continuous gentle force. | The Ormco™ Spark™ Aligner System is<br>indicated for the alignment of teeth<br>during orthodontic treatment of<br>malocclusion in patients with permanent<br>dentition (i.e. all second molars). The<br>Ormco™ Spark™ Aligner System positions<br>teeth by way of continuous gentle force. |
| Mode of Action | Alignment of teeth by application of<br>continuous gentle force, by sequential<br>use of preformed plastic trays,<br>fabricated based on doctor's<br>prescription. | Orthodontic tooth movement occurs<br>through forces applied by the appliance to<br>the dentition as each tooth follows the<br>programmed displacement based on the<br>doctor's prescription. |
| Process and<br>Method of Use | Scans and prescription are sent to<br>NEOLab by the doctor. Treatment is<br>planned by NEOLab, and reviewed and<br>approved by doctor. Aligners are<br>fabricated and shipped to doctor. Each<br>preformed plastic tray is worn by the<br>patient as prescribed by the dental<br>practitioner. | Doctor uploads patient's dental scans into<br>proprietary software; doctor uses<br>software for case viewing and treatment<br>planning; Ormco technician receives case<br>and uses proprietary 3D software to<br>generate models or the aligners based on<br>the prescription (desired outcome);<br>Doctor approves treatment plan and final<br>treated state; manufacturer crafts and<br>produces aligners; aligners and ships them<br>to doctor, who them provides them to the<br>patient, confirming fit and design. |
| Material | Thermoplastic polyurethane-polyester<br>composite resin | Thermoplastic polyurethane-polyester<br>composite resin |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |