The DenMat Orthodontic Aligner consists of a series of clear plastic trays, which fit over a patient's teeth, and move the teeth by external force a small amount daily. This material is the only patient contacting material, there are no lubricants, coatings, or colorants. The dental professional determines the ultimate movement needed, and an FDA-cleared software design tool is used to produce a treatment series of aligners to achieve this goal. The trays are produced when the software design tool outputs a file to a 3-D printer, which produces a resin model. The resin used to manufacture the model has been tested for cytotoxicity and has been shown to be non-cytotoxic. The positive mold is cleaned with isopropyl alcohol prior to vacuum forming the aligner. The resin model is then used with the FDA-cleared plastic material to thermoform the plastic aligner. The aligners, once formed, are rinsed with distilled water only, and air dried. Depending on the prescription, 10 to 15 aligners are produced for a single patient set. Each aligner is worn for 2 weeks, and the dental professional checks progress during treatment.

AI/ML Overview

This FDA 510(k) summary does not contain the detailed study information to complete the table for Acceptance Criteria and Reported Device Performance, nor does it provide other specific details such as sample sizes for test and training sets, data provenance, expert qualifications, or adjudication methods for a diagnostic device.

The document is a declaration of substantial equivalence for a medical device (DenMat Orthodontic Aligners) to a previously cleared predicate device (Clear Image Aligners). For such devices, the primary demonstration of safety and effectiveness is often through comparisons to existing, legally marketed devices, rather than conducting new clinical trials with detailed performance metrics.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list acceptance criteria or reported device performance metrics in the way one might expect for a diagnostic or algorithmic device that produces quantitative outputs. Instead, the "performance" is demonstrated through substantial equivalence to a predicate device.

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance (as stated in comparison)
Indications for Use: Alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.	"Same": The DenMat Orthodontic Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Mode of Action: Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays.	"Same": Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays.
Method of Use: Each preformed plastic tray is worn by the patient as prescribed by the orthodontist/dentist prior to using the next sequential aligner tray.	"Same": Each preformed plastic tray is worn by the patient as prescribed by the orthodontist/dentist prior to using the next sequential aligner tray.
Material: Essix Ace plastic (K062828)	"Same": Essix Ace plastic (K062828)
Software Used during manufacturing: Use of 3Shape Ortho System (K171634/K152086)	"Same": Use of 3Shape Ortho System (K171634/K152086)
Classification: Class II, Orthodontic Plastic Bracket, Product Code NXC	"Same": Class II, Orthodontic Plastic Bracket, Product Code NXC
Prescription or OTC: Prescription	"Same": Prescription
Provided Non-Sterile: Yes	"Same": Yes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document because this is not a study reporting specific performance data from a test set. The submission focuses on demonstrating equivalency to an already cleared device, not on presenting novel performance study results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. This type of detail is typically associated with studies evaluating diagnostic accuracy, which is not the focus of this 510(k) submission for an orthodontic aligner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Similar to the above, adjudication methods are relevant for studies establishing ground truth, which is not documented here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not conducted as part of this submission, nor is it mentioned. This device is a physical orthodontic aligner for tooth movement, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not conducted or reported here. While the manufacturing process includes "FDA-cleared software design tool," the performance being assessed is of the physical aligner itself through substantial equivalence. The software's performance would have been assessed in its own 510(k) submission (K171634/K152086 for 3Shape Ortho System).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the safety and effectiveness established for the predicate device, Clear Image Aligners (K183643). The DenMat Orthodontic Aligner claims substantial equivalence based on sharing identical design, manufacturing materials, intended use, principles of operation, and technical characteristics. Therefore, the "ground truth" for the current submission is the established regulatory clearance of the predicate device, implying its safety and effectiveness.

8. The sample size for the training set

This information is not provided. This is not a study that involved machine learning model training.

9. How the ground truth for the training set was established

This information is not provided. This is not a study that involved machine learning model training.

Summary

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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.

December 20, 2019

DenMat Holdings, LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K192470

Trade/Device Name: DenMat Orthodontic Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 3, 2019 Received: December 4, 2019

Dear Prithul Bom:

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192470

Device Name DenMat Orthodontic Aligner

Indications for Use (Describe)

The DenMat Orthodontic Aligners are in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

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.

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FORM FDA 3881 (7/17)

Page 1 of 1

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510(k) Summary 5

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, DenMat Holdings LLC is hereby submitting this 510(k) summary.

Submitter [510(k) owner]

DenMat Holding, LLC 1017 W. Central Avenue Lompoc. CA 93436

Company Contact

Tom Juarez Director RA/QA DenMat P: (805) 346-3780 C: (805) 345-0632 tjuarez@denmat.com

Submitted Device Information

Trade Name: DenMat Orthodontic Aligner Common Name: Aligner, sequential Classification Name: Orthodontic Plastic Bracket, Dental Devices

Classification Information

Classification: Class II Classification Regulation: 21 CFR 872.5470 Classification Product Code: NXC

Legally Marketed Predicate Devices

The DenMat Orthodontic Aligner manufactured by DenMat Holdings, LC (DenMat) is substantially equivalent to the following device currently in commercial use:

Device Trade Name: Clear Image Aligners
Specialty Appliance Works, Inc.
Address: 4905 Hammond Industrial Drive, Cumming, GA 30041
510(k) number:

Manufacturer:

●

K183643 NXC
. Product Code:

Submitted Device Description

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coatings, or colorants. The dental professional determines the ultimate movement needed, and an FDA-cleared software design tool is used to produce a treatment series of aligners to achieve this goal. The trays are produced when the software design tool outputs a file to a 3-D printer, which produces a resin model. The resin used to manufacture the model has been tested for cytotoxicity and has been shown to be non-cytotoxic. The positive mold is cleaned with isopropyl alcohol prior to vacuum forming the aligner.

The resin model is then used with the FDA-cleared plastic material to thermoform the plastic aligner. The aligners, once formed, are rinsed with distilled water only, and air dried. Depending on the prescription, 10 to 15 aligners are produced for a single patient set. Each aligner is worn for 2 weeks, and the dental professional checks progress during treatment.

Intended Use

The DenMat Orthodontic Aligner is intended to be used under the supervision of a dentist/orthodontist after a comprehensive dental exam has been completed and the patient has been cleared for orthodontic treatment. The dentist/orthodontist takes a scan/impressions that are then sent to the lab where aligners are fabricated and sent back to the dentist to confirm fit and function and then used by a patient in the home/work/leisure environment. The aligner is to be used 20-22 hours per day for 2 weeks, then be replaced by the next aligner in the series, until prescribed tooth movement is achieved.

The patient is instructed in the care of the aligner to maintain clarity of plastic and continued force on teeth and instructed to return to their dentist/orthodontist for any issues with aligner fit or pain.

Indications for Use:

The DenMat Orthodontic Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Substantial Equivalence

The DenMat Orthodontic Aligner is substantially equivalent to the predicate device, in which the basic features and intended uses are essentially the same. The identical 3-D design software and plastic thermoform material are used by both manufacturers. The software and material have both been cleared by the FDA under their own 510(k)s.

The DenMat Orthodontic Aligner system is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the Clear Image Aligners, and raises no new issues of safety or

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effectiveness.

COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The similarities and differences between the predicate and proposed aligners are:

Property orCharacteristic	Proposed DeviceDenMat Holdings, LLCDenMat OrthodonticAligner	Predicate DeviceSpecialty Appliance Works,Inc.Clear Image AlignersK183643	Comments
Device ClassificationName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Same
Product Code	NXC	NXC	Same
Classification	II	II	Same
Indications for Use	The DenMat OrthodonticAligners are indicated for usein the alignment of permanentteeth through orthodontictreatment of misalignmentand malocclusion.	The Clear Image Alignersare indicated for use in thealignment of permanentteeth through orthodontictreatment of misalignmentand malocclusion.	Same
Mode of Action	Alignment of teeth byapplication of continuousgentle force, by sequentialuse of preformed plastictrays.	Alignment of teeth byapplication of continuousgentle force, by sequentialuse of preformed plastictrays.	Same
Method of Use	Each preformed plastic trayis worn by the patient asprescribed by theorthodontist/dentist prior tousing the next sequentialaligner tray.	Each preformed plastic trayis worn by the patient asprescribed by theorthodontist/dentist prior tousing the next sequentialaligner tray.	Same
Material	Essix Ace plastic(K062828)	Essix Ace plastic(K062828)	Same
Prescription or OTC	Prescription	Prescription	Same
Software Used duringmanufacturing	Use of 3Shape OrthoSystem (K171634/K152086)	Use of 3Shape OrthoSystem(K171634/K152086)	Same
Provided Non-Sterile	Yes	Yes	Same

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Summary of Substantial Equivalence:

Based on the information presented in this submission, DenMat Holdings, LLC concludes that the DenMat Orthodontic Aligners are substantially equivalent to the predicate device in regard to indications for use, design and technology.

Regulation Number and Section

§ 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.