DentCare Aligners

K222918 · Dentcare Dental Lab Pvt , Ltd. · NXC · Nov 25, 2022 · Dental

Device Facts

• Record ID: K222918
• Device Name: DentCare Aligners
• Applicant: Dentcare Dental Lab Pvt , Ltd.
• Product Code: NXC · Dental
• Decision Date: Nov 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DentCare Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligner guide teeth to their final position by way of continuous gentle forces.

Device Story

DentCare Aligners are transparent, medical-grade thermoplastic (co-polyester or co-polymer) aligners used for orthodontic tooth movement. The device is fabricated via thermoforming based on precise treatment planning. The process utilizes 3Shape Ortho System software for digital planning and manufacturing. Aligners are patient-removable, intended for single-patient use, and worn 20-22 hours per day. The device applies continuous gentle forces to guide teeth to their final position. Used in clinical settings by dental professionals to treat malocclusion; the output is a series of custom-molded aligners that physically reposition teeth over time, benefiting patients by correcting dental alignment.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including material property characterization (density, water absorption, tensile strength, elongation, E-modulus per ASTM standards) and biocompatibility testing (ISO 10993-5, 10993-10, 10993-11, 10993-23).

Technological Characteristics

Materials: Co-polyester or co-polymer. Manufacturing: Thermoforming. Form factor: Transparent, patient-removable, custom-molded aligners. Energy source: None (passive). Connectivity: None. Sterility: Non-sterile. Mechanical specs: Density 1.19 g/cm³ (ASTM D1505), Water absorption 0.5% (ASTM D570), Tensile Strength 41 MPa (ASTM D882), Elongation at Break 179% (ASTM D882), E-modulus 1462 MPa (ASTM D882).

Indications for Use

Indicated for alignment of permanent teeth in patients with misalignment and malocclusion via continuous gentle forces.

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

• Clear Aligner (K210373)

Reference Devices

• 3Shape Ortho System (K180941)

Submission Summary (Full Text)

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November 25, 2022

DentCare Dental Lab Pvt Ltd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, Illinois 60504

Re: K222918

Trade/Device Name: DentCare Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 23, 2022 Received: September 26, 2022

Dear Manoj Zacharias:

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,

# Bobak Shirmohammadi -S

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) K222918

Device Name

DentCare Aligners

Indications for Use (Describe)

DentCare Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligner guide teeth to their final position by way of continuous gentle forces.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510K SUMMARY

## K222918

## As required by 21CFR§807.92(c)

## A. APPLICANT INFORMATION

| Applicant | DentCare Dental Lab Pvt Ltd. |
|----------------|--------------------------------------------------------------------|
| Address | NAS Road, 130 Jn. Muvattupuzha, Ernakulam<br>Kerala- 686661, India |
| Phone | 91 4852835112 |
| Fax | |
| E-mail | [e-mail] |
| Contact Person | Mr. Abin Johns Raju |
| Designation | Head R & D |
| Contact Number | 91 9072666345 |
| Contact Email | [e-mail] |
| Date Submitted | 23 September 2022 |

#### B. DEVICE IDENTIFICATION

| Name of the device | DentCare Aligners |
|--------------------------------------|------------------------------|
| Product proprietary or<br>trade name | |
| Common or usual name | Aligner, Sequential |
| Regulation name | Orthodontic Plastic Brackete |
| Device Classification | Class II |
| Product Code | NXC |
| Regulation Number | 21 CFR 872.5470 |
| Review Panel | Dental |

#### C. PREDICATE DEVICE

| Legally Marketed devices | Clear Aligner |
|-----------------------------|---------------|
| that Equivalency is claimed | |
| 510(K) Number | K210373 |
| Regulatory Class | Class II |
| Product code | NXC |

#### D. REFERENCE DEVICE

This reference device- 3 Shape Ortho System ™ is the software which used for the manufacturing process of DentCare Aligners.

| Sponsor | 3Shape A/S |
|---------------------|-----------------------------|
| Device Name & Model | Ortho System™ |
| 510 (K) Number | K180941 |
| Product Code | PNN (Orthodontics Software) |
| Regulation Number | 21 CFR 872.5470 |
| Regulation Class | Class II |

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#### E. DESCRIPTION OF THE DEVICE:

The DentCare Aligners are transparent medical grade thermoplastic materials moulded for the use in orthodontic alignment of teeth from one position to another. The DentCare Aligners are used in correcting various malocclusions. Hence it requires precise treatment planning before fabrication. Thorough understanding of the process and steps are required before proceeding to provide a successful aligner treatment.

#### F. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:

DentCare Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion. The aligner guide teeth to their final position by way of continuous gentle forces.

| Characteristics | Device Performance | | Remarks |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Predicate Device | Subject Device | |
| 510(K) Number | K210373 | K222918 | --- |
| Name of device | Clear Aligner | DentCare Aligners | Similar |
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Regulation Name | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Same |
| Product Code | NXC | NXC | Same |
| Class | Class II | Class II | Same |
| Indications for use | This device is indicated<br>for use in the alignment<br>of all permanent<br>dentition through<br>orthodontic treatment of<br>misalignment and<br>malocclusion | DentCare Aligners are<br>indicated for use in the<br>alignment of permanent<br>teeth through<br>orthodontic treatment of<br>misalignment and<br>malocclusion. The<br>aligner guide teeth to<br>their final position by<br>way of continuous<br>gentle forces. | Similar |
| Prescription or OTC | Prescription Use | Prescription Use | Same |
| Materials | Co-polyester or Co-<br>polymer | Co-polyester or Co-<br>polymer | Same |
| Mode of Action | Continuous gentle force<br>applied to teeth to<br>achieve movement | Continuous gentle force<br>applied to teeth to<br>achieve movement | Same |

#### G. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

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| Characteristics | Device Performance | | Remarks |
|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|---------|
| | Predicate Device | Subject Device | |
| 510(K) Number | K210373 | K222918 | --- |
| Manufacturing Method | Thermoforming | Thermoforming | Same |
| Patient Removable | Yes | Yes | Same |
| Single use/Reuse | Repeated use by a<br>single patient | Repeated use by a single<br>patient | Same |
| Duration of Use | 20-22 hours per day | 20-22 hours per day | Same |
| Software Use | Yes | Yes | Same |
| Sterility | Non Sterile | Non Sterile | Same |
| Biocompatibility | | | |
| Primary Skin Irritation-<br>ISO 10993 | Passed the tests as per<br>ISO 10993-10:2010<br>(E) | Passed the tests as per<br>ISO 10993-23:2021 | Similar |
| Dermal Sensitization-<br>ISO 10993-10:2010(<br>E) | Passed the tests as per<br>ISO 10993-10:2010<br>(E) | Passed the tests as per<br>ISO 10993-10:2010<br>(E) | Same |
| In vitro cytotoxicity-<br>ISO 10993-5:2009(E) | Passed the tests as per<br>ISO 10993-5:2009(E) | Passed the tests as per<br>ISO 10993-5:2009(E) | Same |
| Acute systemic<br>toxicity- ISO10993-11-<br>2017(E) | No data available | Passed the tests as per<br>ISO10993-11-2017(E) | ----- |

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.

## H. NON-CLINICAL TESTING SUMMARY

Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the clear aligner was performed. The device material tested to the following standards and meets the acceptance criteria.

- Density (g/cm3) ASTM D1505 A
- > Water absorption 24 h/23°C (%) ASTM D570
- A Tensile Strength (Mpa) ASTM D882
- Elongation at Break (%) ASTM D882 A
- A E-modulus (Mpa) ASTM D882

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### Performance Data:

| PROPERTIES | GUIDLINE | VALUE OBTAINED |
|--------------------------------|------------|----------------|
| Density | ASTM D1505 | 1.19 g/cm³ |
| Water absorption,<br>24 h/23 ℃ | ASTM D570 | 0.5% |
| Tensile Strength | ASTM D882 | 41 MPa |
| Elongation at Break | ASTM D882 | 179% |
| E-modulus | ASTM D882 | 1462 MPa |

#### CLINICAL TESTING SUMMARY I.

Not applicable - Clinical data is not needed for most devices cleared by the 510(K) process.

## J. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrate that the subject device in 510(K) submission DentCare Aligners are safe, as effective and performs as well as the legally marketed predicate device cleared under K210373.