Clear Image Aligners

K183643 · Specialty Appliance Works, Inc. · NXC · Jan 3, 2019 · Dental

Device Facts

• Record ID: K183643
• Device Name: Clear Image Aligners
• Applicant: Specialty Appliance Works, Inc.
• Product Code: NXC · Dental
• Decision Date: Jan 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

Clear Image Aligners are patient-specific, removable, sequential plastic trays prescribed by orthodontists or dentists to treat tooth misalignment and malocclusion. A trained technician uses 3Shape orthodontic software to design the treatment plan based on clinician recommendations. The device applies gentle, continuous force to teeth through minor, sequential changes in tray geometry. Aligners are provided non-sterile; patients wear them as directed to gradually reposition teeth. The system relies on established orthodontic principles for sequential tooth movement.

Clinical Evidence

No clinical data. Substantial equivalence is supported by established performance of sequential aligners (product code NXC) since 1998 and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Sequential thermoformed polyurethane aligners (Essix Ace plastic, K062828). Design utilizes 3Shape orthodontic software (K171634/K152086). Non-sterile, patient-specific, removable form factor. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for alignment of permanent teeth in patients requiring orthodontic treatment for misalignment and malocclusion.

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

• Derby Dental Laboratory Custom Clear Aligner System (K173785)

Reference Devices

• 3Shape orthodontic software (K171634/K152086)
• Essix Ace plastic (K062828)

Submission Summary (Full Text)

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Specialty Appliance Works, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313

Re: K183643

Trade/Device Name: Clear Image Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 21, 2018 Received: December 26, 2018

Dear Mark Job:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

January 3, 2019

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Digitally signed by Mary Mary S. = S. Runner -S3 19.01.03 - 5.3 - Date: 2019.01.03
> Runner - 5.3 - Date: 2019.01.03
> Runner - 5.3 - 09:06:24 -05'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 Indications for Use See PRA Statement below. 510(k) Number (if known)

Device Name Clear Image Aligners

Indications for Use (Describe)

The Clear Image Aligners are indicated for use in the alignment 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)

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Image /page/3/Picture/0 description: The image shows the logo for Specialty Appliances. The logo consists of a cluster of gray circles on the left, arranged in a circular pattern. To the right of the circles, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller font size.

# 510(k) Summary

| Date Prepared: | November 16, 2018 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Specialty Appliance Works, Inc.<br>4905 Hammond Industrial Drive<br>Cumming, GA 30041 |
| Contact: | Carolyn Thomas<br>Quality Manager<br>Specialty Appliance Works, Inc.<br>[phone]<br>[e-mail] |
| Proprietary Name: | Clear Image Aligners |
| Common Name: | Sequential Aligners |
| Classification: | 21 CFR 872.5470: Orthodontic plastic bracket; Class II |
| Product Code: | NXC |
| Predicate Device: | K173785, Derby Dental Laboratory Custom Clear Aligner<br>System |

#### Intended Use / Indications:

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

### Device Description:

The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series.

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Image /page/4/Picture/0 description: The image contains a logo for "Specialty Appliances". The logo features a circular design on the left, composed of multiple smaller circles arranged in a pattern. To the right of the circular design, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller font size.

Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.

#### Non-Clinical Testing:

Specialty Appliance Works, Inc. has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required.

#### Clinical Testing:

The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the Clear Image Aligners to the predicate device.

| Property or<br>Characteristic | Proposed Device<br>Specialty Appliance Works,<br>Inc.<br>Clear Image Aligners | Predicate Device<br>Derby Dental Laboratory<br>Custom Clear Aligner<br>System (K173785) | Comments |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Device Classification<br>Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same as K173785 |
| Product Code | NXC | NXC | Same as K173785 |
| Classification | II | II | Same as K173785 |
| Indications for Use | The Clear Image Aligners<br>are indicated for use in the<br>alignment of permanent<br>teeth through orthodontic<br>treatment of misalignment<br>and malocclusion. | The Custom Clear Aligner<br>System is indicated for use<br>in the alignment of<br>permanent teeth through<br>orthodontic treatment of<br>misalignment and<br>malocclusion. | Same as K173785 |
| Mode of Action | Alignment of teeth by<br>application of continuous | Alignment of teeth by<br>application of continuous | Same as K173785 |

## Predicate Device Comparison:

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Image /page/5/Picture/0 description: The image contains the logo for Specialty Appliances. The logo features a circular design composed of several smaller circles on the left side. To the right of the circular design, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller, sans-serif font.

| Property or<br>Characteristic | Proposed Device<br>Specialty Appliance Works, Inc.<br>Clear Image Aligners | Predicate Device<br>Derby Dental Laboratory<br>Custom Clear Aligner System (K173785) | Comments |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Method of Use | gentle force, by sequential<br>use of preformed plastic<br>trays.<br>Each preformed plastic tray<br>is worn by the patient as<br>prescribed by the<br>orthodontist/dentist prior to<br>using the next sequential<br>aligner tray. | gentle force, by sequential<br>use of preformed plastic<br>trays.<br>Each preformed plastic tray<br>is worn by the patient as<br>prescribed by the dental<br>practitioner, usually a few<br>weeks prior to using the<br>next sequential aligner tray. | Same as K173785 |
| | Material | Essix Ace plastic<br>(K062828) | Thin thermoformed<br>polyurethane |
| Prescription or OTC | Prescription | Prescription | Same as K173785 |
| Software Used during<br>manufacturing | Use of 3Shape Ortho<br>System<br>(K171634/K152086) | Use of 3Shape Ortho<br>System (K152086) | Same as K173785 |
| Provided Non-Sterile | Yes | Yes | Same as K173785 |

### Summary of Substantial Equivalence:

Based on the information presented in this submission, Specialty Appliance Works, Inc. concludes that the Clear Image Aligners are substantially equivalent to the predicate device in regard to indications for use, design and technology.