Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the design process as being performed by dental professionals using proprietary technology, not AI/ML. While image processing is mentioned, it's described as interpreting a series of images, which doesn't necessarily imply AI/ML.

Therapeutic

Yes
The device is used for the alignment of teeth as part of orthodontic treatment, which is a therapeutic intervention.

Diagnostic

No

This device is described as an orthodontic treatment system that aligns teeth using physical aligners, not as a device that diagnoses a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of "clear, thin, plastic removable aligners" which are physical hardware components. While software is used in the design process, the final medical device delivered to the patient is a physical product.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the "alignment of permanent teeth during orthodontic treatment of malocclusions." This is a therapeutic purpose, not a diagnostic one.
Device Description: The device is a physical aligner worn by the patient to move teeth. It's a treatment device, not a device used to examine specimens from the human body.
Input: The input is a digital scan or physical impression of the teeth, which is used for fabrication, not for analyzing biological samples.
Anatomical Site: The anatomical site is permanent teeth, which are being treated directly, not being sampled for analysis.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Product codes

NXC

Device Description

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and custom-made by dental professionals using uLab Systems proprietary technology. The aligners are made of aesthetic and medical grade materials chosen by doctors for their patients. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

digital scan

Anatomical Site

permanent teeth (in the context of orthodontic treatment of malocclusions)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professional (dentist/orthodontist) / dental office

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)

Biocompatibility testing for the aligner materials was completed in accordance with ISO 10993 per the following:
- Part 5: Cytotoxicity Elution -MEM
- Part 10: Intracutaneous/Intradermal Reactivity
- Part 10: Maximimzation for Delayed-Type Hypersensitivity
- Part 10: Oral Mucosa Irritation Test
- The test results demonstrate that the material is biocompatible for the intended use.
Additionally, biocompatibility testing for the finished device was completed in accordance with ISO 10993 per the following:
- Part 5: Cytotoxicity Elution -MEM
- The test results demonstrate the finished device is biocompatible for the intended use.
Design verification and process validation testing was completed, demonstrating that the manufacturing process and finished device meet product requirement specifications.
User validation testing was completed, demonstrating that the device confirms to the user needs and intended use.
Packaging verification and shelf life testing was completed, supporting the labeled shelf life of the device.
Physical properties testing has been provided by the material manufacturer.

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

Not Found

Predicate Device(s)

K180241

Reference Device(s)

K173785, K182826, K171295

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 contains two logos. On the left is the Department of Health & Human Services logo, which features an abstract design of a human figure. To the right of this is the FDA logo, with the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 11, 2020

uLab Systems, Inc. % Sylvia Erickson Regulatory Consultant Sylvia Erickson Consulting 157 Ruby Avenue San Carlos, California 94070

Re: K192596

Trade/Device Name: ULab Systems Dental Aligner Kit Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 3, 2020 Received: January 3, 2020

Dear Sylvia Erickson:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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

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Indications for Use

510(k) Number (if known) K192596

Device Name uLab Systems Dental Aligner

Indications for Use (Describe)

The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

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)

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K192596

510(k) Summary

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information:

uLab Systems, Inc. 3 Lagoon Drive Suite 180 Redwood City, CA 94065

Contact Person: Charlie Wen Phone: 650-804-1397

Submission Correspondent:

Sylvia Erickson Principal, Sylvia Erickson Consulting

Device Information:

Trade Name:	uLab Systems Dental Aligner Kit
Common Name:	Sequential Aligner
Classification Name:	Orthodontic Plastic Bracket
Classification Regulation:	21CFR 872.5470
Device Class:	II
Product Code:	NXC

Primary Predicate:

Ortho Caps GmBH Orthocaps Twinaligner, K180241

Reference Predicates:

Derby Dental Laboratory Custom Clear Aligner System, K173785 Sybron Dental Specialties Ormco Spark Aligner System, K182826 uLab Systems uDesign, K171295

Date Prepared:

February 10, 2020

Device Description:

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The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and custom-made by dental professionals using uLab Systems proprietary technology. The aligners are made of aesthetic and medical grade materials chosen by doctors for their patients. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

Indications for Use:

The uLab Systems Dental Aligner is indicated for the alignment teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

The subject and predicate devices share intended use for alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The subject and predicate device are based on the following same technological elements:

Both devices are clear plastic sequential aligners.
. Both devices have the same intended use for alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
. Both devices have the same indications for use.
Both devices have the same principle of operation.
Both devices are fabricated based on an orthodontic treatment plan designed by the aligner manufacturer's technicians from digital scans of the patient's teeth in an untreated state.
Both devices are made of thermoplastic.

The only differences between the subject and device are the following:

. The subject device may alternatively be fabricated based on an orthodontic treatment plan designed by a dental practitioner.
. The subject device materials are the same material used in the reference predicates, whereas the primary predicate device material is an unspecified thermoplastic. The subject and primary predicate devices otherwise share the same technological characteristics.
The subject device is not designated for use during a specific time of day.

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Attribute	Subject Device	Predicate Device
	uLab Systems Dental Aligner (uLab
Systems)	Orthocaps Twinaligner (Ortho Caps
GmBH)
K180241
Indications
for Use	The ULab System Dental Aligner is
indicated for the alignment of permanent
teeth during orthodontic treatment of
malocclusions by way of continuous
gentle forces.	The Orthocaps TwinAligner® System
is indicated for the alignment of
teeth during orthodontic treatment
of malocclusions by way of
continuous gentle forces.
Device
Description	A series of custom-made removable clear
plastic orthodontic aligners that
sequentially position teeth by way of
continuous gentle force.	A series of custom-made removable
clear plastic orthodontic aligners that
sequentially position teeth by way of
continuous gentle force.
Principles of
Operation	Each preformed plastic tray is worn in
sequence by the patient as prescribed by
the dental practitioner.

Orthodontic movement occurs through
continuous gentle forces applied to the
dentition as each tooth follows the
programmed displacement based on a
doctor's prescription. | Each preformed plastic tray is worn in
sequence by the patient as
prescribed by the dental practitioner.

Orthodontic movement occurs
through continuous gentle forces
applied to the dentition as each tooth
follows the programmed
displacement based on a doctor's
prescription. |
| Aligner
Design
Process | Dental software, the uLab Systems
uDesign, K171295, for tooth alignment
uses digital scan (untreated state) to
generate the image of a final, provisional
treated state and then interprets a series
of images that represent intermediate
teeth states. The dental practitioner then
reviews these images and has the option
to reject, make or request modifications
to the set-up prior to approving it for
aligner fabrication. Once the dental
practitioner approves the treatment plan,
the software converts the files to
produce the series of 3D models used to
produce thermoformed aligners. | Standard dental software for tooth
alignment uses digital scan
(untreated state) to generate the
image of a final, provisional treated
state and then interprets a series of
images that represent intermediate
teeth states. The dental practitioner
then reviews these images and has
the option to reject or request
modifications to the set-up prior to
approving it for aligner fabrication.
Once the dental practitioner
approves the treatment plan, the
software converts the files to
produce the series of 3D models used
to produce thermoformed aligners. |
| Material | Zendura A (thin thermoformed
polyurethane) or Zendura FLX
(copolyester and polyurethane
composite) | Thermoplastic |
| Features | Aligners made from different materials as
prescribed by physician | Aligners made from different
materials as prescribed by physician
for daytime or nighttime use |
| OTC or Rx | Rx | Rx |
| Attribute | Subject Device | Predicate Device |
| | uLab Systems Dental Aligner (uLab
Systems) | Orthocaps Twinaligner (Ortho Caps
GmBH)
K180241 |
| Sterilization | No | No |

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Performance Data:

The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:

Biocompatibility testing for the aligner materials was completed in accordance with ISO 10993 per the following:
- O Part 5: Cytotoxicity Elution -MEM
- Part 10: Intracutaneous/Intradermal Reactivity O
- Part 10: Maximimzation for Delayed-Type Hypersensitivity O
- Part 10: Oral Mucosa Irritation Test O

The test results demonstrate that the material is biocompatible for the intended use.

Additionally, biocompatibility testing for the finished device was completed in accordance with ISO 10993 per the following:

Part 5: Cytotoxicity Elution -MEM о
The test results demonstrate the finished device is biocompatible for the intended use.
Design verification and process validation testing was completed, demonstrating that the manufacturing process and finished device meet product requirement specifications.
. User validation testing was completed, demonstrating that the device confirms to the user needs and intended use.
. Packaging verification and shelf life testing was completed, supporting the labeled shelf life of the device.
Physical properties testing has been provided by the material manufacturer.

Summary:

The uLab Systems Dental Aligner Kit has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the uLab Systems Dental Aligner is substantially equivalent to the cleared predicate device.