Vivid Aligners

K190003 · Orthodent Laboratory, Inc. · NXC · Nov 6, 2019 · Dental

Device Facts

• Record ID: K190003
• Device Name: Vivid Aligners
• Applicant: Orthodent Laboratory, Inc.
• Product Code: NXC · Dental
• Decision Date: Nov 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vivid Aligner is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Device Story

Vivid Aligner is an intraoral thermoformed plastic aligner system; used for orthodontic tooth movement. Input: patient dental scan data or physical impressions. Process: digital models imported into dental software for treatment planning; sequential 3D models created to plan tooth movement; 3D printer creates molds; plastic sheets thermoformed over molds. Output: series of sequential aligners. Usage: worn 20-22 hours/day; removed for eating/cleaning. Context: prescribed by dental practitioner; treatment plan requires doctor approval. Benefit: progressive realignment of teeth to desired position via continuous gentle force.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence supported by bench testing of physical properties (ASTM D638, D790, D792, D570, D5420) and biocompatibility testing (ISO 10993 Parts 3, 5, 10, 11).

Technological Characteristics

Material: thermoformed polyurethane. Fabrication: 3D printed molds from digital CAD/CAM models. Connectivity: uses 3Shape software for treatment planning. Standards: ASTM D638 (tensile), D790 (flexural), D792 (specific gravity), D570 (water absorption), D5420 (impact). Biocompatibility: ISO 10993 compliant.

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

• Smylio Invisible Clear Aligner (K173784)
• Derby Dental, Custom Clear Aligner System (K173785)
• Ormco Spark Aligner System (K182826)

Reference Devices

• 3Shape Software (K180491)
• 3Shape Software (K152086)

Submission Summary (Full Text)

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November 6, 2019

Orthodent Laboratory, Inc. % Robert Dean President Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo, New York 14209

Re: K190003

Trade/Device Name: Vivid Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 24, 2018 Received: October 8, 2019

Dear Robert Dean:

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 Nandkumar, Ph.D. Acting 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) K190003

Device Name Vivid Aligner

Indications for Use (Describe)

Vivid Aligner is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K190003 510(k) Summary

| Submitter Name: | Orthodent Laboratory, Inc. |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address:<br>Phone Number: | 166 Chandler St. Suite 301, Buffalo, NY 14207<br>800-837-1552 |
| Contact Person:<br>Date Prepared: | Mr. Michael Wright<br>October 29, 2019 |
| Device Trade Name: | Vivid Aligner |
| Common Name<br>Classification Name<br>Number<br>Product Code<br>Regulatory Class | Aligner, Sequential<br>Orthodontic Plastic Bracket<br>21 CFR 872.5470<br>NXC<br>2 |
| Primary Predicate<br>Device:<br>Reference Predicate<br>Devices: | K173784, Smylio Invisible Clear Aligner<br>K173785 Derby Dental, Custom Clear Aligner System<br>K182826 Ormco Spark Aligner System |
| Statement of<br>Indications for<br>Use: | Vivid Aligner is indicated for use in the alignment of permanent teeth<br>through orthodontic treatment of misalignment and malocclusion. |
| Device Description<br>and Summary of<br>Technological<br>Characteristics: | Orthodent Laboratory, Inc. Vivid Aligner are intraoral thermoformed<br>plastic aligner that are worn 20 to 22 hours per day and are designed<br>to be used in a sequence, each aligner providing a gentle continuous<br>force, to allow for the movement of teeth to the final desired position.<br>The aligner are to be removed for eating and for cleaning. Orthodent<br>Laboratory, Inc. Vivid Aligner are fabricated using a three-step<br>process. The first step is to obtain the dimensions and details of the<br>patient's baseline dentition. This is generally done using an oral scan<br>data or a physical impression. This scanned data (digital CAD/CAM<br>models or patient models) are imported into specialized dental<br>software for treatment planning. The second step is the printing of 3D<br>models of the treatment plan for use in step 3 (thermoforming). In the<br>second step, Orthodent Laboratory utilizes a software application to<br>plan the treatment by creating a series of sequential models that<br>gradually position the teeth into their final desired position. The<br>treatment plan is sent to the doctor for approval. Upon approval, a 3D<br>printer is used to create the molds needed for each treatment step to<br>provide the surface around which the aligner is thermoformed. The<br>final step is the thermoforming of a plastic sheet material to each of the<br>sequential treatment steps. This process is done using a standard<br>thermoforming equipment and the appropriate material as outlined in<br>this submission. |
| Mechanism of Action: | In the same manner as the predicate device, each aligner exerts<br>gentle force to achieve progressive realignment of the teeth until<br>the final correction has been attained. This is based on the<br>treatment plan and proceeds over time. |
| Device Testing: | Biocompatibility<br>Contact of the device to the patient's oral tissue requires the<br>Aligner material to be biocompatible. The thermoplastic<br>polyurethane has been tested according to Good Laboratory<br>Practices for its biocompatibility according to ISO 10993, as<br>follows:<br>Part 3 (Bacterial Mutagenicity – Ames Assay)<br>Part 5 (Cytotoxicity Elution - MEM),<br>Part 10 (Intracutaneous/Intradermal) Reactivity),<br>Part 10 (Oral Mucosa Irritation),<br>Part 10 (Maximization for Delayed-Type Hypersensitivity),<br>Part 11 (Subacute Systemic Toxicity) |
| Animal Human Testing | No animal or human testing were required for this product<br>because it is composed of the same materials and has a similar<br>design and method of manufacture/fabrication in comparison to<br>the predicate device. |
| Non-Clinical Physical<br>Properties Testing: | Device material tested to the following standards and meet the acceptance<br>criteria<br>• Elongation @ Yield (%) ASTM D638<br>• Elongation @ Break (%) ASTM D638<br>• Tensile @ Yield (PSI) ASTM D638<br>• Tensile Strength (PSI) ASTM D638<br>• Tensile Modulus (PSI) ASTM D638<br>• Flexural Modulus (PSI) ASTM D790<br>• Flexural Strength (PSI) ASTM D790<br>• Specific Gravity g.cm3 ASTM D792<br>• Water Absorption (%)24 hours @ 23°C ASTM D570<br>• Gardner Impact Strength 23°C J/mm ASTM D5420, |

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Differences between ODL Vivid Aligner compared to
predicate device

| ODL Vivid Aligner | S & E Effect | Smylio K173784 |
|-----------------------------|---------------------|-----------------------------|
| ODL prepares the | No effect, both | Smylio K173784 doctor |
| treatment plan in Step 2 of | treatment plans are | prepares the treatment plan |
| the manufacturing process | doctor approved. | |
| for subsequent approval by | | |
| a doctor. | | |

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| ODL uses 3Shape Software<br>K180491 | No effect, 3Shape<br>Software K180491 is<br>FDA 510K cleared, the<br>use/manufacturing<br>process has been<br>validated by ODL | Smylio uses 3Shape Software<br>K152086 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| ODL biocompatibility<br>summary applied ISO<br>10993<br>• -3, Biological evaluation<br>of medical devices — Part<br>3: Tests for genotoxicity,<br>carcinogenicity and<br>reproductive toxicity<br>• -5, Biological evaluation<br>of medical devices — Part<br>5: Tests for in vitro<br>cytotoxicity<br>• -10, Biological evaluation<br>of medical devices -- Part<br>10: Tests for irritation and<br>skin sensitization<br>• -11, Biological evaluation<br>of medical devices — Part<br>11: Tests for systemic<br>toxicity | No effect on<br>biocompatibility. ISO<br>7405 directly<br>references the same<br>test as conducted<br>using ISO 10993 et.al. | Smylio biocompatibility<br>summary references ISO<br>7405, Dentistry - Evaluation<br>of biocompatibility of<br>medical devices used in<br>dentistry |

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| Trade Name: | Submission Device<br>Orthodent Laboratory, Inc.<br>Vivid Aligner | Predicate Device<br>K173784<br>Smylio Invisible Clear Aligner |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K173785 |
| Manufacturer | Orthodent Laboratories Inc. | Smylio |
| Classification #,<br>Product Code<br>Device Class | 21 CFR 852.5470<br>NXC 2 | 21 CFR 852.5470<br>NXC 2 |
| Indications for Use | Vivid Aligner is indicated for use in the<br>alignment of permanent teeth through<br>orthodontic treatment of misalignment and<br>malocclusion. | Smylio Invisible Clear Aligner is indicated<br>for use in the alignment of permanent<br>teeth through orthodontic treatment of<br>misalignment and malocclusion. |
| Mode of Action | Alignment of teeth by application of<br>continuous gentle force, by sequential use<br>of preformed plastic trays. | Alignment of teeth by application of<br>continuous gentle force, by sequential use<br>of preformed plastic trays. |
| Method of Use | Each preformed plastic tray is worn by<br>the patient as prescribed by the dental<br>practitioner, usually a few weeks prior to<br>using the next sequential Aligner tray. | Each preformed plastic tray is worn<br>by the patient as prescribed by the<br>dental practitioner, usually a few<br>weeks prior to using the next<br>sequential Aligner tray. |
| Material | Thin thermoformed<br>polyurethane | Thin thermoformed<br>polyurethane |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |

The intended use of the Orthodent Laboratory, Inc. Vivid Aligner is the same to that of the primary predicate device as they are both intended for correcting dental malocclusion in patients with permanent dentition.

It has a similar technological principle, and the device characteristics are similar to the predicate device. The mode of operation and the material used to fabricate the aligner trays is the same as the predicate device. There are minor differences comparing Orthodent Laboratory, Inc. Vivid Aligner to the predicate Smylio Invisible Clear Aligner which do affect substantial equivalence or safety and effectiveness.

## Substantial Equivalence Conclusion

Thus, based on the above it can be concluded that Orthodent Laboratory, Inc. Vivid Aligner is substantially equivalent to the predicate device.