(199 days)
No
The description explicitly states the use of standard dental software (Ortho Analyzer) for planning and design, and there is no mention of AI or ML in the device description or the "Mentions AI, DNN, or ML" section.
Yes
The device is indicated for the "treatment of tooth malocclusion" and "positions teeth by way of continuous gentle force," which describes a therapeutic action to correct a medical condition.
No
The device description clearly states "The Argen Clear Aligner is comprised of a series of clear plastic removable aligner trays that are designed to correct tooth malocclusions". This indicates it is a treatment device, not a diagnostic one. While software is used for "orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models" as part of the planning, the Argen Clear Aligner itself is the physical aligner for treatment.
No
The device description clearly states the device is comprised of "a series of clear plastic removable aligner trays," which are physical hardware components. While software is used in the design process, the final device delivered to the patient is a physical product.
Based on the provided information, the Argen Clear Aligner is 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Argen Clear Aligner's Function: The Argen Clear Aligner is a physical device used to mechanically move teeth to correct malocclusion. It does not analyze any biological specimens.
- Intended Use: The intended use is for the treatment of tooth malocclusion, which is a physical correction, not a diagnostic process based on analyzing bodily fluids or tissues.
- Device Description: The description details the physical components (plastic trays), the design process based on dental scans and software, and the role of the dental professional in prescribing and fitting the device. There is no mention of analyzing biological samples.
Therefore, the Argen Clear Aligner falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Argen Clear Aligner is comprised of a series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner based on an assessment of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment.
The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth / dentition
Indicated Patient Age Range
Patients with permanent dentition (i.e. all second molars).
Intended User / Care Setting
Prescribing dentist or orthodontist, and patient.
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)
Non-Clinical Performance Testing: Reference Dentsply's K062828.
Biocompatibility Testing: Reference Dentsply's K062828.
Animal and human performance testing are not required for this product type.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in a sans-serif font.
June 7, 2019
Argen Corporation Mr. Paul Cascone Senior Vice President, Research and Development % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
Re: K183229
Trade/Device Name: Argen Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 6, 2019 Received: May 8, 2019
Dear Patsy Trisler:
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 medical devices and radiation-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.
Srinivas Nandkumar, Ph.D. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183229
Device Name
Argen Clear Aligner
Indications for Use (Describe)
The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.
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
510(k) Summary K183229
| Submitter Name: | Argen Corporation |
|---|---|
| Submitter Address: | 5855 Oberlin Drive |
| San Diego, CA 92121 | |
| Phone Number: | 858-455-7900 |
| Contact Person: | Mr. Paul Cascone |
| Senior Vice President, Research and Development | |
| Date Prepared: | June 5, 2019 |
| Device Trade | |
| Name: | Argen Clear Aligner |
| Common Name | Aligner, Sequential |
| Classification Name | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Primary Predicate | |
| Device: | K981095; The Align System; Align Technology, Inc. |
| Reference Devices: | K180941; Ortho System™; 3Shape A/S |
| K062828; Mouthguard and Aligner Materials, Dentsply International | |
| Indications for Use | |
| Statement | The Argen Clear Aligner is indicated for the treatment of tooth |
| malocclusion in patients with permanent dentition (i.e. all second | |
| molars). The aligner positions teeth by way of continuous gentle | |
| force. | |
| Device Description | |
| and Summary of | |
| Technological | |
| Characteristics | The Argen Clear Aligner is comprised of a series of clear plastic |
| removable aligner trays that are designed to correct tooth | |
| malocclusions without the use of conventional wire and bracket | |
| orthodontic technology. | |
| A dental health professional (e.g. orthodontist or dentist) prescribes | |
| the Argen Clear Aligner based on an assessment of the patient's | |
| teeth, determines a course of treatment with the system, and | |
| completes a prescription form using a standard dental software | |
| used for tooth alignment. The series of plastic trays are designed in | |
| accordance with the physician's prescription using standard dental | |
| software for planning the tooth alignment. | |
| The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by | |
| 3Shape A/S (K180941). It is used for management of 3D scanned | |
| orthodontic models, orthodontic diagnosis by measuring, analyzing, | |
| inspecting and visualizing 3D scanned orthodontic models, virtual | |
| planning of orthodontic treatments by simulating tooth movements, | |
| and design of orthodontic appliances based on 3D scanned | |
| orthodontic models. |
4
The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design.
The thermoplastic material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.
Mechanism of The mechanism of action is similar to the predicate device. Action Orthodontic tooth movement, achieved over time with the clear aligner systems, occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on the dental professional's prescription. The trays are held in place by pressure and can be removed by the patient at any time.
Device Testing Non-Clinical Performance Testing: Reference Dentsply's K062828.
Biocompatibility Testing: Reference Dentsply's K062828.
Animal | Human Testing
Animal and human performance testing are not required for this product type.
Comparison to A comparison of the Argen Clear Aligner to the predicate device Predicate Device: shows the following (See Substantial Equivalence Comparison Table on last page of this Summary):
- I The indications for use is similar.
- . The mechanism of action is similar.
- . The polyurethane used to make the aligners is similar to the predicate device, a single-layer thermoformable material:
- . Dental software is used in the design and manufacture of both Argen Clear Aligner and the predicate.
- . The method of manufacture and customizing the aligners is similar.
Substantial There are no notable differences between the Argen Clear Aligner Equivalence and the predicate. Therefore it can be concluded that the Argen Clear Aligner is substantially equivalent to the Align Technology Conclusion predicate device.
5
| Trade Name: | Argen Clear Aligner | The Align System |
|---|---|---|
| 510(k) Number | K183229 | K981095 |
| Manufacturer | Argen Corporation | Align Technology, Inc. |
| Classification # & | ||
| Product Code | ||
| Class | 21 CFR 852.5470 | |
| NXC | ||
| 2 | 21 CFR 852.5470 | |
| NXC | ||
| 2 | ||
| Intended Use | The Argen Clear Aligner is | |
| indicated for the treatment of | ||
| tooth malocclusion in patients | ||
| with permanent dentition (i.e. all | ||
| second molars). The aligner | ||
| positions teeth by way of | ||
| continuous gentle force. | The Align System is indicated | |
| for the treatment of tooth | ||
| malocclusion in patients with | ||
| permanent dentition (i.e. all | ||
| second molars). The Align | ||
| System positions teeth by way | ||
| of continuous gentle force. | ||
| 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. | ||
| Method of Use | Each preformed plastic tray is | |
| worn by the patient as | ||
| prescribed by the dental | ||
| practitioner, usually a few | ||
| weeks prior to using the next | ||
| sequential aligner tray. | Each preformed plastic tray is | |
| worn by the patient as | ||
| prescribed by the dental | ||
| practitioner, usually a few | ||
| weeks prior to using the next | ||
| sequential aligner tray. | ||
| Polymer | ||
| Material(s) | Thermoformable polymer single | |
| layer | Thermoformable polymer single | |
| layer | ||
| Mechanical | ||
| Performance | ||
| Testing: | Reference: Dentsply: K062828 | Reference: Dentsply: K062828 |
| Biocompatibility | ||
| Testing | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |