(102 days)
No
The description focuses on the physical aligners and the use of FDA-cleared software for design, but there is no mention of AI or ML in the process of determining the treatment plan or designing the aligners.
Yes
The device is described as moving teeth through orthodontic treatment of misalignment and malocclusion, which is a therapeutic purpose.
No
Explanation: The device description states its purpose is to move teeth through external force for orthodontic treatment, and it relies on a dental professional and software to determine movement, not to diagnose a condition.
No
The device description clearly states that the device consists of "a series of clear plastic trays" which are physical components that contact the patient and exert force. While software is used in the design process, the final medical device is a physical product.
Based on the provided information, the DenMat Orthodontic Aligners are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- DenMat Orthodontic Aligners Function: The description clearly states that these aligners are used for the "alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion." They are physical devices that apply force to teeth to move them.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. The process involves taking scans or impressions of the teeth, using software to design the aligners, and then manufacturing physical trays.
The device is a therapeutic device used for orthodontic treatment, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The DenMat Orthodontic Aligners are in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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)
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.
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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
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,
4
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
5
effectiveness.
COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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 effectiveness.
The similarities and differences between the predicate and proposed aligners are:
| Property or
Characteristic | Proposed Device
DenMat Holdings, LLC
DenMat Orthodontic
Aligner | Predicate Device
Specialty Appliance Works,
Inc.
Clear Image Aligners
K183643 | Comments |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Device Classification
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Product Code | NXC | NXC | Same |
| Classification | II | II | Same |
| Indications for Use | The DenMat Orthodontic
Aligners are indicated for use
in the alignment of permanent
teeth through orthodontic
treatment of misalignment
and malocclusion. | The Clear Image Aligners
are indicated for use in the
alignment of permanent
teeth through orthodontic
treatment of misalignment
and malocclusion. | Same |
| Mode of Action | Alignment of teeth by
application of continuous
gentle force, by sequential
use of preformed plastic
trays. | Alignment of teeth by
application of continuous
gentle force, by sequential
use of preformed plastic
trays. | Same |
| 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. | Each preformed plastic tray
is worn by the patient as
prescribed by the
orthodontist/dentist prior to
using the next sequential
aligner tray. | Same |
| Material | Essix Ace plastic
(K062828) | Essix Ace plastic
(K062828) | Same |
| Prescription or OTC | Prescription | Prescription | Same |
| Software Used during
manufacturing | Use of 3Shape Ortho
System (K171634/K152086) | Use of 3Shape Ortho
System
(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.