Toothsi, Smilealigners

K223338 · Makeo Healthcare Technologies Private Limited · NXC · Feb 9, 2023 · Dental

Device Facts

• Record ID: K223338
• Device Name: Toothsi, Smilealigners
• Applicant: Makeo Healthcare Technologies Private Limited
• Product Code: NXC · Dental
• Decision Date: Feb 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.

Device Story

Toothsi & SmileAligners are thermoformed, removable, patient-specific dental appliances; used for orthodontic treatment of malocclusion. Aligners are worn by patients in a prescribed sequence to exert continuous gentle force on teeth, facilitating progressive repositioning. Device is used in a home setting by the patient; orthodontists monitor progress. Aligners are manufactured from BPA-free thermoplastic sheets (0.5 mm to 1.0 mm thickness). Treatment involves wearing aligners for 20-22 hours daily, with changes every 7-14 days per prescription. Output is the physical movement of teeth toward the desired alignment. Benefits include correction of malocclusion through a wearable, removable appliance.

Clinical Evidence

Bench testing only. Testing included surface finishing, thermoformed thickness verification, shape accuracy after 15 days of simulated use, and 3D model shape accuracy for punching effectiveness. All tests were accepted.

Technological Characteristics

Thermoformed, BPA-free thermoplastic dental aligners. Thickness ranges from ~0.5 mm to ~1.0 mm. Non-sterile, single-user device. Biocompatibility compliant with ISO 10993. Mechanical actuation via continuous gentle force.

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)

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 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.

February 9, 2023

AMPA Orthodontics Private Limited % Sanjeev Gupta Managing Consultant Intrust A301/A Green Heritage, Plot 79-80, Sector 20 Kharghar, Maharashtra 410210 India

Re: K223338

Trade/Device Name: Toothsi&SmileAligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC. Dated: October 29, 2022 Received: November 1, 2022

Dear Sanjeev Gupta:

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

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

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/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,

# Bobak Shirmohammadi -S

For Michael Adjodha, M.ChE.,CQIA 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

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

# Indications for Use

510(k) Number (if known) K223338

Device Name Toothsi&SmileAligners

Indications for Use (Describe)

The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These by patient with monitoring of improvement by orthodontists.

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

#### 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 word "toothsi" in a red, sans-serif font. A curved line is below the "t" in "toothsi", resembling a smile. A four-pointed star is above the "i" in "toothsi".

## 510 k Summary - Substantial Equivalence Discussion K223338

| A. Name and Address of:<br>Manufacturer | AMPA Orthodontics Private Limited<br>1st Floor, Empire Plaza B Wing<br>Lal Bahadur Shastri Marg<br>Vikhroli West<br>Mumbai 400083<br>Maharashtra, India<br>Phone/Fax: [phone]<br>Contact Person: Dr. Manjul Jain ([e-mail]) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### B. Device Details:

- a) Trade Name: Toothsi & SmileAligners
- b) Common Name: Clear Dental Aligners
- c) Classification Name: Aligner, Sequential
- d) Product Code: NXC
- C. Predicate Device: ClearCorrect System (K113618)
- D. Device Description: The Clear Dental Aligners are thermoformed, orthodontic wearable & removable dental appliances that, when worn in the prescribed sequence and duration, progressively reposition the permanent malocclusion teeth. These aligners could be soft, medium, or hard as per prescription set by an orthodontist, and to exert the desired & continuous gentle force to progressively position the teeth. Each aligner is made of thermoforming BPA free material sheets.
- E. Intended Use The patient specific set of Clear Dental Aligners are indicated for the treatment of tooth malocclusion in patients having permanent dentition. These Aligners position teeth by way of continuous gentle force. These are for self-use by patient with monitoring of improvement by orthodontists.

Ver 01 Date 2022-12-20

013/1

[phone]

1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

[e-mail] X 0 www.toothsi.in

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

Image /page/4/Picture/0 description: The image shows the word "toothsi" in red font. The "t" in toothsi is lowercase, and the two "o"s are connected. There is a curved line under the first "t" that resembles a smile. There is a four-pointed star to the right of the "i".

## F: Comparison of proposed device with predicate device for

| Equivalence<br>Points | Clear Dental Aligners | ClearCorrect System<br>(K113618) | Comparison |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | AMPA Orthodontics Pvt. Ltd. | CLEARCORRECT LLC | N/A |
| Product Code | NXC | NXC | Equivalent |
| Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Equivalent |
| Intended<br>Use/Indications<br>for Use | The patient specific set of Clear<br>Dental Aligners are indicated for<br>the treatment of tooth<br>malocclusion in patients having<br>permanent dentition.<br>These<br>Aligners position teeth by way of<br>continuous gentle force. These are<br>for self-use by patient with<br>monitoring of improvement by<br>orthodontists. | The ClearCorrect System is<br>indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition (i.e.<br>all second molars).<br>The ClearCorrect System<br>positions teeth by way of<br>continuous gentle force | Equivalent |
| Mechanism of<br>Action | Continuous gentle force to<br>move the teeth | Continuous gentle force to<br>move the teeth | Equivalent |
| Material of<br>Construction | Thermoplastic | Thermoplastic | Equivalent |
| Aligner Material<br>Thickness<br>(For different<br>aligner set) | ~0.5 mm to ~1.0 mm as per<br>treatment plan | Soft (0.5 mm) | Equivalent |
| | | Medium (0.62 mm) | |
| | | Hard (0.75 mm)<br>Ultra Hard (1 mm) | |
| Biocompatible | Complies with ISO 10993 (FR# 2-<br>248 & 2-296) | ISO 10993-1 | Equivalent |
| Prescription<br>Steps | Approximately 7-14 days/aligner<br>set as per prescription | Soft (1 Week) | Equivalent |
| | | Medium (1 Week) | |
| | | Hard (1 Week) | |
| Daily Duration of<br>wear | At least 20-22 hours | 17 hours a day | Equivalent |
| Sterile | Non-Sterile | Non-Sterile | Equivalent |
| Single-Use | Single User Use | Single User Use | Equivalent |

#### Ver 01 Date 2022-12-20

(O)

013/2

1* floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

- [phone]
K

X

0

[e-mail]

- www.toothsi.in

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

Image /page/5/Picture/0 description: The image shows the word "toothsi" in red font. The "t" in toothsi is stylized with a curved line underneath, resembling a smile. There is a four-pointed star to the right of the "i" in toothsi. The font is rounded and sans-serif.

## G. Performance Testing Bench (Non-clinical)

The following bench testing was performed as part of Design Verification with purpose define in column 2 of Table 2 below. The reports are presented in sequence along with data tables and figures as applicable in 018_Performance Testing Bench. No separate annexure has been created for this section.

| Table 2: Summary of bench testing performed on design samples of clear dental<br>aligners | | | Test Outcome |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------|--------------|
| Sr.<br>No | Purpose of Bench Testing | Report Number | |
| 1 | Surface finishing after polishing by two<br>methods | Report No. AO/DV/R1<br>dated 31-12-2021 | Accepted |
| 2 | Thickness of aligners after thermoforming<br>with reference to aligner sheets | Report No.: AO/DV/R2<br>Dated 31-12-2021 | Accepted |
| 3 | Aligner shape accuracy after mimicked use<br>for 15 days | Report No.: AO/DV/R7<br>Dated 10-01-2022 | Accepted |
| 4 | 3D Model shape accuracy for effectiveness<br>of aligner punching as per treatment plan | Report No.: AO/DV/R3<br>Dated 10-01-2022 | Accepted |

The above four tests relate to safety (Sr. No 1 & 4) and performance (Sr. No 2, 3 and 4) of the clear aligners. No comparative testing with predicate device was possible since clear dental aligners are patient specific devices made after treatment plan.

### H. Substantial Equivalence Discussion

Comparison of specifications with predicate device: The Section F-Table 1 above summarizes the comparison of subject device with predicate device.

- a) Similarities: As it emerges from the review of Section F-Table 1 the characteristics related to Intended Use, Mechanism of Action, Material Thickness, Material of Construction, Prescription Steps are equivalent between predicate and subject devices.
- b) Differences: The duration of wearing aligner is around 17 hours in predicate device and around 22 hours for subject device. This difference is subjective and does not alter safety and performance of the devices. Such difference majorly emerges from the user actions.

Ver 01 Date 2022-12-20

[phone]

[e-mail]

1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

0 www.toothsi.in

X

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

Image /page/6/Picture/0 description: The image shows the word "toothsi" in red font. The "tooth" part of the word is above a curved line, also in red, that resembles a smile. To the right of the "i" is a red star.

- c) Standards Testing: AMPA Orthodontics Private Limited has performed biocompatibility testing of the subject device by application of ISO 10993 standards which has also been followed by the predicate device manufacturer.
Conclusions: We, therefore, conclude that Clear Dental Aligner manufactured by AMPA Orthodontics Private Limited have substantial equivalence with ClearCorrect Aligners (K113618) Manufactured by ClearCorrect LLC.

Ver 01 Date 2022-12-20

(O)

013/4

1st floor, Empire Plaza B Wing, Lal Bahadur Shashtri Marg, Vikhroli (West), Mumbai - 400083

[phone] [e-mail]

X

www.toothsi.in