(130 days)
No
The description focuses on standard dental software for planning and design based on physician input, with no mention of AI or ML capabilities for diagnosis, treatment planning, or design automation.
Yes
The device is indicated for the treatment of tooth malocclusion, which is a medical condition, and it positions teeth by continuous gentle force, thus providing a therapeutic effect.
No
The device (Argen Clear Aligner) is an orthodontic appliance used for treatment (moving teeth), not for diagnosing conditions. While an associated software (Ortho Analyzer) is mentioned for diagnosis, the aligner itself is a therapeutic device.
No
The device description clearly states that the device is comprised of "series of clear plastic removable aligner trays" which are physical hardware components. While software is used in the design process, the final medical device provided to the patient is a physical product.
Based on the provided information, the Argen Clear Aligner and Argen Clear Aligner Premium are not In Vitro Diagnostic (IVD) devices.
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 Function: The Argen Clear Aligner is a physical device used to mechanically move teeth to correct malocclusion. It works by applying force to the teeth, not by analyzing biological samples.
- Intended Use: The intended use is for the "treatment of tooth malocclusion," which is a physical correction, not a diagnostic test.
- Device Description: The description details the materials and manufacturing process of the physical aligner trays.
- Input: The input is intraoral scans or physical impressions of the teeth, which are physical representations, not biological specimens for analysis.
The device is clearly a medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Argen Clear Aligner and Argen Clear Aligner Premium are 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 aligners are comprised of 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 or the Argen Clear Aligner Premium based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions 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.
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 materials used in the manufacture of the Argen aligners are similar to the materials commonly used in many dental and orthodontic appliances including clear aligners. The Argen Clear Aligner is made of a thermoplastic polyurethane resin and the Argen Clear Aligner Premium is made of a thermoplastic polyurethane-polyester composite resin.
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
patients with permanent dentition (i.e. all second molars).
Intended User / Care Setting
dental health professional (e.g. orthodontist or dentist) / Not Found
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
A Risk Analysis was performed according to ISO 14971:2012 and documentation was included in the 510(k) to assess the modification and the impact on performance and safety.
Physical properties and Biocompatibility testing were referenced in the Predicate device and the two Reference device submissions.
Verification and validation activities were assessed on the proposed device to ensure consistency between the aligner series' design and manufactured aligners. The results show the proposed device met all pre-defined acceptance criteria.
Key Metrics
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
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February 10, 2020
Argen Corporation % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K192846
Trade/Device Name: Argen Clear Aligner, Argen Clear Aligner Premium Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 10, 2020 Received: January 13, 2020
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.
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
1
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,
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
2
Indications for Use
510(k) Number (if known) K192846
Device Name
Argen Clear Aligner and Argen Clear Aligner Premium
Indications for Use (Describe)
The Argen Clear Aligner and Arger Premium are 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) |
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SECTION 5
510(k) SUMMARY
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Argen Corporation |
| Submitter Address: | 5855 Oberlin Drive |
| San Diego, CA 92121 | |
| Contact Person: | Mr. Paul Cascone |
| Senior Vice President, Research and Development | |
| Telephone #: | 858-455-7900 |
| Date Prepared: | January 17, 2020 |
| II. DEVICE | |
| Device Trade Name: | Argen Clear Aligner and Argen Clear Aligner Premium |
| Common Name: | Aligner, Sequential |
| Classification Name | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Review Panel | Dental |
| III. PREDICATE DEVICE | Primary Predicate: |
| K183229, Argen Clear Aligner, Argen Corporation | |
| Reference Devices: | |
| K113618, ClearCorrect LLC, ClearCorrect System | |
| K182826, Ormco Spark Aligner System, Sybron Dental | |
| Specialties | |
| K180941 Ortho System™, 3Shape A/S | |
| IV. DEVICE | |
| DESCRIPTION and | |
| SUMMARY OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | The Argen clear aligners are comprised of 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 or the Argen Clear | |
| Aligner Premium based on an assessment of the patient's | |
| teeth. The dental health professional (dentist/orthodontist) | |
| takes intraoral scans or physical impressions 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. | |
| 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 materials used in the manufacture of the | |
| Argen aligners are similar to the materials commonly used in | |
| many dental and orthodontic appliances including clear | |
| aligners. The Argen Clear Aligner is made of a | |
| thermoplastic polyurethane resin and the Argen Clear | |
| Aligner Premium is made of a thermoplastic polyurethane- | |
| polyester composite resin. | |
| V. INDICATIONS FOR | |
| USE | The Argen Clear Aligner and Argen Clear Aligner |
| Premium are 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. | |
| VI. COMPARISON OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | |
| WITH THE | |
| PREDICATE AND | |
| REFERENCE | |
| DEVICES | The Argen clear aligners have the same intended use as the |
| predicate and reference devices. There are no fundamental | |
| technological differences between the Predicate and the | |
| modified device. The only modification(s) are as noted - | |
| different thermoplastic materials than used for the predicate | |
| aligner. Comparison Tables A (for the Argen Clear Aligner) | |
| and B (for the Argen Clear Aligner Premium) follow on the | |
| next pages. | |
| VII. SUMMARY OF | |
| PERFORMANCE | |
| DATA AND DESIGN | |
| CONTROLS | A Risk Analysis was performed according to ISO |
| 14971:2012 and documentation was included in the 510(k) | |
| to assess the modification and the impact on performance | |
| and safety. | |
| Physical properties and Biocompatibility testing were | |
| referenced in the Predicate device and the two Reference | |
| device submissions. | |
| Verification and validation activities were assessed on the | |
| proposed device to ensure consistency between the aligner | |
| series' design and manufactured aligners. The results show | |
| the proposed device met all pre-defined acceptance criteria. | |
| VIX. SUBSTANTIAL | |
| EQUIVALENCE | |
| CONCLUSION | The information and data provided in this Special 510(k) |
| establish that the modified device is substantially equivalent | |
| in the intended use, design, principle of operation, | |
| technology, and materials to the predicate. |
4
5
Table A – Substantial Equivalence Comparison [For proposed Argen Clear Aligner]
| | Predicate Device
K183229 | Proposed Device
K192846 | Reference Device
K113618 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------|
| Device Name | Argen Clear Aligner | Argen Clear Aligner | Clear Correct System |
| Manufacturer | Argen Corporation | Argen Corporation | Clear Correct, LLC |
| Classification
Name
Product Code
Class | 21 CFR 872.5470
Orthodontic Plastic
Bracket
NXC
2 | Same | Same |
| 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. | Same | Same |
| Mode of Action | The appliance applies
gentle forces on teeth
according to the plan
prescribed by the doctor. | Same | Same |
| Description of
Use | Each removable
preformed plastic tray is
worn by the patient as
prescribed by the doctor,
usually a few weeks
prior to using the next
sequential aligner tray. | Same | Same |
| Material | Thermoplastic
polyurethane resin | Same | Same |
| Software Used
for Treatment
Planning/
Manufacture | Yes | Same software | Yes |
| Prescription Use | Rx | Same | Same |
| Biocompatibility | Yes, shown to meet
requirements | Same | Same |
| Verification and
Validation
Testing | Yes, performed | Yes, performed | Presumed performed |
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Table B – Substantial Equivalence Comparison [For proposed Argen Clear Aligner Premium]
| | Predicate Device
K183229 | Proposed Device
K192846 | Reference Device
K182826 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------|
| Device Name | Argen Clear Aligner | Argen Clear Aligner
Premium | Ormco™ Spark™ Aligner System |
| Manufacturer | Argen Corporation | Argen Corporation | Sybron Dental
Specialties |
| Classification
Name | 21 CFR 872.5470
Orthodontic Plastic
Bracket | Same | Same |
| Product Code
Class | NXC
2 | Same | Same |
| 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. | Same | Same |
| Mode of Action | The appliance applies
gentle forces on teeth
according to the plan
prescribed by the
doctor. | Same | Same |
| Description of
Use | Each removable
preformed plastic tray is
worn by the patient as
prescribed by the
doctor, usually a few
weeks prior to using the
next sequential aligner
tray. | Same | Same |
| Material | Thermoplastic
polyurethane polyester
composite resin | Same | Same |
| Software Used
for Treatment
Planning/
Manufacture | Yes | Same software | Yes |
| Prescription Use | Rx | Same | Same |
| Biocompatibility | Yes, shown to meet
requirements | Same | Same |
| Verification and
Validation
Testing | Yes, performed | Yes, performed | Presumed performed |