(60 days)
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.
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.
The provided text describes DentCare Aligners, an orthodontic device, and details its non-clinical testing for 510(k) clearance.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated based on material properties, with acceptance criteria implicit in the guideline standards and the reported values indicating compliance.
| Property | Guideline (Acceptance Criteria Implicit) | Reported Device Performance (Value Obtained) |
|---|---|---|
| Density | ASTM D1505 | 1.19 g/cm³ |
| Water absorption, 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 |
Additionally, the biocompatibility tests against ISO standards represent acceptance criteria:
| Biocompatibility Test | Standard (Acceptance Criteria Implicit) | Result |
|---|---|---|
| Primary Skin Irritation | ISO 10993-23:2021 | Passed the tests as per ISO 10993-23:2021 |
| Dermal Sensitization | ISO 10993-10:2010(E) | Passed the tests as per ISO 10993-10:2010(E) |
| In vitro cytotoxicity | ISO 10993-5:2009(E) | Passed the tests as per ISO 10993-5:2009(E) |
| Acute systemic toxicity | ISO10993-11-2017(E) | Passed the tests as per ISO10993-11-2017(E) (No data for predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for the material property tests. These are typically conducted on a small number of material samples according to the respective ASTM standards.
The data provenance is not explicitly stated as "country of origin for data" or "retrospective/prospective." However, the tests are non-clinical (material property and biocompatibility evaluations) rather than patient-based studies. The applicant, DentCare Dental Lab Pvt Ltd., is based in India.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the studies are non-clinical material and biocompatibility tests, not expert-opinion-based evaluations. The "ground truth" here is the adherence to established international standards (ASTM and ISO).
4. Adjudication Method
Not applicable for non-clinical material and biocompatibility testing. The "adjudication" is determined by whether the test results meet the specified criteria of the applicable standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "CLINICAL TESTING SUMMARY I. Not applicable - Clinical data is not needed for most devices cleared by the 510(K) process." This indicates no human-in-the-loop performance evaluation was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device, DentCare Aligners, is a physical medical device (orthodontic aligners), not an algorithm or AI software for diagnosis or treatment planning. While software (3Shape Ortho System™) is used in the manufacturing process, the clearance is for the aligners themselves, not the software's standalone performance.
7. The Type of Ground Truth Used
For the material property tests, the "ground truth" is the established scientific and engineering principles embodied in the ASTM standards (e.g., how to correctly measure density, tensile strength). For biocompatibility, the "ground truth" is compliance with the safety thresholds and methodologies defined by the ISO 10993 series of standards.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied as this is not an AI/ML device requiring a training phase for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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) | |
|---|---|
| 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}------------------------------------------------
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, ErnakulamKerala- 686661, India |
| Phone | 91 4852835112 |
| Fax | |
| info@dentcaredental.com | |
| Contact Person | Mr. Abin Johns Raju |
| Designation | Head R & D |
| Contact Number | 91 9072666345 |
| Contact Email | abinjohns@dentcaredental.com |
| Date Submitted | 23 September 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | DentCare Aligners |
|---|---|
| Product proprietary ortrade 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 |
{4}------------------------------------------------
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 PlasticBracket | Orthodontic PlasticBracket | Same |
| Product Code | NXC | NXC | Same |
| Class | Class II | Class II | Same |
| Indications for use | This device is indicatedfor use in the alignmentof all permanentdentition throughorthodontic treatment ofmisalignment andmalocclusion | DentCare Aligners areindicated for use in thealignment of permanentteeth throughorthodontic treatment ofmisalignment andmalocclusion. Thealigner guide teeth totheir final position byway of continuousgentle forces. | Similar |
| Prescription or OTC | Prescription Use | Prescription Use | Same |
| Materials | Co-polyester or Co-polymer | Co-polyester or Co-polymer | Same |
| Mode of Action | Continuous gentle forceapplied to teeth toachieve movement | Continuous gentle forceapplied to teeth toachieve movement | Same |
G. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
{5}------------------------------------------------
| 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 asingle patient | Repeated use by a singlepatient | 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-ISO 10993 | Passed the tests as perISO 10993-10:2010(E) | Passed the tests as perISO 10993-23:2021 | Similar |
| Dermal Sensitization-ISO 10993-10:2010(E) | Passed the tests as perISO 10993-10:2010(E) | Passed the tests as perISO 10993-10:2010(E) | Same |
| In vitro cytotoxicity-ISO 10993-5:2009(E) | Passed the tests as perISO 10993-5:2009(E) | Passed the tests as perISO 10993-5:2009(E) | Same |
| Acute systemictoxicity- ISO10993-11-2017(E) | No data available | Passed the tests as perISO10993-11-2017(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
{6}------------------------------------------------
Performance Data:
| PROPERTIES | GUIDLINE | VALUE OBTAINED |
|---|---|---|
| Density | ASTM D1505 | 1.19 g/cm³ |
| Water absorption,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.
§ 872.5470 Orthodontic plastic bracket.
(a)
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.(b)
Classification. Class II.