Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a software application used for treatment planning and creating sequential models, but it does not mention or imply the use of AI or ML algorithms for this process. The process appears to be based on pre-defined steps and doctor approval, not adaptive learning or pattern recognition.

Therapeutic

Yes.
The device is used for orthodontic treatment, which involves the physical manipulation of teeth to correct misalignment and malocclusion, fitting the definition of a therapeutic intervention.

Diagnostic

No

The device is described as an orthodontic treatment device (aligner) used for teeth alignment, not for diagnosing conditions. The 'treatment planning' mentioned refers to planning the teeth movement, not diagnosing a disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines the fabrication of physical, intraoral thermoformed plastic aligners, which are hardware components. While software is used in the treatment planning and creation of 3D models, the final medical device is a physical object.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vivid Aligner is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The Vivid Aligner is an intraoral device that is placed directly in the patient's mouth to physically move teeth. It does not analyze any biological samples.
The intended use is for the alignment of teeth through orthodontic treatment. This is a therapeutic purpose, not a diagnostic one.
The device description focuses on the physical fabrication and function of the aligner. It describes how it's made and how it applies force to teeth. There is no mention of analyzing any biological markers or providing diagnostic information.

The process described involves obtaining patient data (scans or impressions), using software for treatment planning, and then fabricating a physical device based on that plan. This is consistent with the manufacturing of a custom medical device for therapeutic use, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

NXC

Device Description

Orthodent Laboratory, Inc. Vivid Aligner are intraoral thermoformed plastic aligner that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligner are to be removed for eating and for cleaning. Orthodent Laboratory, Inc. Vivid Aligner are fabricated using a three-step process. The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Orthodent Laboratory utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

oral scan data or a physical impression

Anatomical Site

Teeth (permanent dentition)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Device Testing: Biocompatibility. Contact of the device to the patient's oral tissue requires the Aligner material to be biocompatible. The thermoplastic polyurethane has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows: Part 3 (Bacterial Mutagenicity – Ames Assay), Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Oral Mucosa Irritation), Part 10 (Maximization for Delayed-Type Hypersensitivity), Part 11 (Subacute Systemic Toxicity). Non-Clinical Physical Properties Testing: Device material tested to the following standards and meet the acceptance criteria: • Elongation @ Yield (%) ASTM D638 • Elongation @ Break (%) ASTM D638 • Tensile @ Yield (PSI) ASTM D638 • Tensile Strength (PSI) ASTM D638 • Tensile Modulus (PSI) ASTM D638 • Flexural Modulus (PSI) ASTM D790 • Flexural Strength (PSI) ASTM D790 • Specific Gravity g.cm3 ASTM D792 • Water Absorption (%)24 hours @ 23°C ASTM D570 • Gardner Impact Strength 23°C J/mm ASTM D5420. Animal Human Testing: No animal or human testing were required for this product because it is composed of the same materials and has a similar design and method of manufacture/fabrication in comparison to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173784, K173785, K182826

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.

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

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

4

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.

5

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

6

| Trade Name: | Submission Device
Orthodent Laboratory, Inc.
Vivid Aligner | Predicate Device
K173784
Smylio Invisible Clear Aligner |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K173785 |
| Manufacturer | Orthodent Laboratories Inc. | Smylio |
| Classification #,
Product Code
Device Class | 21 CFR 852.5470
NXC 2 | 21 CFR 852.5470
NXC 2 |
| Indications for Use | Vivid Aligner is indicated for use in the
alignment of permanent teeth through
orthodontic treatment of misalignment and
malocclusion. | Smylio Invisible Clear Aligner is indicated
for use in the alignment of permanent
teeth through orthodontic treatment of
misalignment and malocclusion. |
| 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. |
| Material | Thin thermoformed
polyurethane | Thin thermoformed
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.