Argen Clear Aligner, Argen Clear Aligner Premium

K192846 · Argen Corporation · NXC · Feb 10, 2020 · Dental

Device Facts

• Record ID: K192846
• Device Name: Argen Clear Aligner, Argen Clear Aligner Premium
• Applicant: Argen Corporation
• Product Code: NXC · Dental
• Decision Date: Feb 10, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System consists of series of clear, removable, thermoformed plastic aligner trays; designed to correct tooth malocclusions via continuous gentle force. Clinician (dentist/orthodontist) performs intraoral scans or physical impressions; uses 3Shape Ortho Analyzer software to plan tooth movements and design appliances. Prescribing physician reviews/approves treatment plan; Argen manufactures trays based on approved model. Patient wears trays as prescribed, transitioning through sequential series to achieve alignment. Used in clinical setting; provides non-invasive alternative to conventional wire/bracket orthodontics.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities confirmed consistency between design and manufactured aligners. Biocompatibility and physical properties were supported by referencing predicate and reference device submissions.

Technological Characteristics

Clear, removable, thermoformed plastic trays. Argen Clear Aligner: thermoplastic polyurethane resin. Argen Clear Aligner Premium: thermoplastic polyurethane-polyester composite resin. Software-driven design and manufacturing. No electronic components or energy sources.

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

• Argen Clear Aligner (K183229)

Reference Devices

• ClearCorrect System (K113618)
• Ormco Spark Aligner System (K182826)
• Ortho System (K180941)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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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## 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<br>San Diego, CA 92121 |
| Contact Person: | Mr. Paul Cascone<br>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<br>Number<br>Product Code<br>Regulatory Class | Orthodontic Plastic Bracket<br>21 CFR 872.5470<br>NXC<br>2 |
| Review Panel | Dental |
| III. PREDICATE DEVICE | Primary Predicate:<br>K183229, Argen Clear Aligner, Argen Corporation<br>Reference Devices:<br>K113618, ClearCorrect LLC, ClearCorrect System<br>K182826, Ormco Spark Aligner System, Sybron Dental<br>Specialties<br>K180941 Ortho System™, 3Shape A/S |
| IV. DEVICE<br>DESCRIPTION and<br>SUMMARY OF<br>TECHNOLOGICAL<br>CHARACTERISTICS | The Argen clear aligners are comprised of series of clear<br>plastic removable aligner trays that are designed to correct<br>tooth malocclusions without the use of conventional wire<br>and bracket orthodontic technology.<br>A dental health professional (e.g. orthodontist or dentist)<br>prescribes the Argen Clear Aligner or the Argen Clear<br>Aligner Premium based on an assessment of the patient's<br>teeth. The dental health professional (dentist/orthodontist)<br>takes intraoral scans or physical impressions of the patient's<br>teeth, determines a course of treatment with the system, and<br>completes a prescription form using a standard dental<br>software used for tooth alignment. The series of plastic<br>trays are designed in accordance with the physician's<br>prescription using standard dental software for planning the<br>tooth alignment.<br>The software system used is Ortho Analyzer, 2019 ver<br>1.8.1.0 by 3Shape A/S (K180941). It is used for |
| | management of 3D scanned orthodontic models, orthodontic<br>diagnosis by measuring, analyzing, inspecting and<br>visualizing 3D scanned orthodontic models, virtual planning<br>of orthodontic treatments by simulating tooth movements,<br>and design of orthodontic appliances based on 3D scanned<br>orthodontic models. |
| | The prescribing physician reviews and approves the model<br>scheme before the molds are produced. Once approved,<br>Argen produces trays, which are formed of clear, thin,<br>thermoformed plastic. The trays are provided to the dental<br>health care professional who provides them to the patient,<br>confirming fit and design. |
| | The thermoplastic materials used in the manufacture of the<br>Argen aligners are similar to the materials commonly used in<br>many dental and orthodontic appliances including clear<br>aligners. The Argen Clear Aligner is made of a<br>thermoplastic polyurethane resin and the Argen Clear<br>Aligner Premium is made of a thermoplastic polyurethane-<br>polyester composite resin. |
| V. INDICATIONS FOR<br>USE | The Argen Clear Aligner and Argen Clear Aligner<br>Premium are indicated for the treatment of tooth<br>malocclusion in patients with permanent dentition (i.e. all<br>second molars). The aligner positions teeth by way of<br>continuous gentle force. |
| VI. COMPARISON OF<br>TECHNOLOGICAL<br>CHARACTERISTICS<br>WITH THE<br>PREDICATE AND<br>REFERENCE<br>DEVICES | The Argen clear aligners have the same intended use as the<br>predicate and reference devices. There are no fundamental<br>technological differences between the Predicate and the<br>modified device. The only modification(s) are as noted -<br>different thermoplastic materials than used for the predicate<br>aligner. Comparison Tables A (for the Argen Clear Aligner)<br>and B (for the Argen Clear Aligner Premium) follow on the<br>next pages. |
| VII. SUMMARY OF<br>PERFORMANCE<br>DATA AND DESIGN<br>CONTROLS | A Risk Analysis was performed according to ISO<br>14971:2012 and documentation was included in the 510(k)<br>to assess the modification and the impact on performance<br>and safety. |
| | Physical properties and Biocompatibility testing were<br>referenced in the Predicate device and the two Reference<br>device submissions. |
| | Verification and validation activities were assessed on the<br>proposed device to ensure consistency between the aligner<br>series' design and manufactured aligners. The results show<br>the proposed device met all pre-defined acceptance criteria. |
| VIX. SUBSTANTIAL<br>EQUIVALENCE<br>CONCLUSION | The information and data provided in this Special 510(k)<br>establish that the modified device is substantially equivalent<br>in the intended use, design, principle of operation,<br>technology, and materials to the predicate. |

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## Table A – Substantial Equivalence Comparison [For proposed Argen Clear Aligner]

| | Predicate Device<br>K183229 | Proposed Device<br>K192846 | Reference Device<br>K113618 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------|
| Device Name | Argen Clear Aligner | Argen Clear Aligner | Clear Correct System |
| Manufacturer | Argen Corporation | Argen Corporation | Clear Correct, LLC |
| Classification<br>Name<br>Product Code<br>Class | 21 CFR 872.5470<br>Orthodontic Plastic<br>Bracket<br>NXC<br>2 | Same | Same |
| Indications for<br>Use | The Argen Clear Aligner<br>is indicated for the<br>treatment of tooth<br>malocclusion in patients<br>with permanent dentition<br>(i.e. all second molars).<br>The aligner positions<br>teeth by way of<br>continuous gentle force. | Same | Same |
| Mode of Action | The appliance applies<br>gentle forces on teeth<br>according to the plan<br>prescribed by the doctor. | Same | Same |
| Description of<br>Use | Each removable<br>preformed plastic tray is<br>worn by the patient as<br>prescribed by the doctor,<br>usually a few weeks<br>prior to using the next<br>sequential aligner tray. | Same | Same |
| Material | Thermoplastic<br>polyurethane resin | Same | Same |
| Software Used<br>for Treatment<br>Planning/<br>Manufacture | Yes | Same software | Yes |
| Prescription Use | Rx | Same | Same |
| Biocompatibility | Yes, shown to meet<br>requirements | Same | Same |
| Verification and<br>Validation<br>Testing | Yes, performed | Yes, performed | Presumed performed |

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## Table B – Substantial Equivalence Comparison [For proposed Argen Clear Aligner Premium]

| | Predicate Device<br>K183229 | Proposed Device<br>K192846 | Reference Device<br>K182826 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------|
| Device Name | Argen Clear Aligner | Argen Clear Aligner<br>Premium | Ormco™ Spark™ Aligner System |
| Manufacturer | Argen Corporation | Argen Corporation | Sybron Dental<br>Specialties |
| Classification<br>Name | 21 CFR 872.5470<br>Orthodontic Plastic<br>Bracket | Same | Same |
| Product Code<br>Class | NXC<br>2 | Same | Same |
| Indications for<br>Use | The Argen Clear Aligner<br>is indicated for the<br>treatment of tooth<br>malocclusion in patients<br>with permanent dentition<br>(i.e. all second molars).<br>The aligner positions<br>teeth by way of<br>continuous gentle force. | Same | Same |
| Mode of Action | The appliance applies<br>gentle forces on teeth<br>according to the plan<br>prescribed by the<br>doctor. | Same | Same |
| Description of<br>Use | Each removable<br>preformed plastic tray is<br>worn by the patient as<br>prescribed by the<br>doctor, usually a few<br>weeks prior to using the<br>next sequential aligner<br>tray. | Same | Same |
| Material | Thermoplastic<br>polyurethane polyester<br>composite resin | Same | Same |
| Software Used<br>for Treatment<br>Planning/<br>Manufacture | Yes | Same software | Yes |
| Prescription Use | Rx | Same | Same |
| Biocompatibility | Yes, shown to meet<br>requirements | Same | Same |
| Verification and<br>Validation<br>Testing | Yes, performed | Yes, performed | Presumed performed |