K Number

Device Name

uLab Systems Dental Aligner Kit

Manufacturer

uLab Systems, Inc.

Date Cleared

2022-02-24

(286 days)

Product Code

NXC

Regulation Number

872.5470

Intended Use

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

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 customized by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K212660

Reference Devices

K192596

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard dental software for generating treatment plans and fabricating aligners based on digital scans and dental professional input. There is no mention of AI, ML, or related concepts in the provided text.

Therapeutic

Yes
The device is indicated for the alignment of teeth during orthodontic treatment of malocclusions, which is a therapeutic purpose.

Diagnostic

The device description clearly states its purpose is for "alignment of teeth during orthodontic treatment of malocclusions" and that it "moves the patient's teeth gradually to the ideal position," indicating a therapeutic rather than diagnostic function.

SaMD (Software as a Medical Device)

The device description explicitly states that the device is a "Dental Aligner Kit" consisting of "clear, thin, plastic removable aligners," which are physical hardware components. While software is used in the design and fabrication process, the final device includes hardware.

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 teeth during orthodontic treatment of malocclusions." This is a direct treatment of a physical condition within the body.
Device Description: The device is a physical aligner worn by the patient to move teeth. It's a therapeutic device, not a diagnostic one.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. The software mentioned is used for planning the treatment, not for diagnosis.
Anatomical Site: The device acts on the teeth, which are part of the patient's anatomy, not a sample taken from the body.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. 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 teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

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

NXC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

digital scan

Anatomical Site

teeth/dentition

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)

The performance testing remains unchanged from the company's own reference device submission, K192596. The performance testing for the subject device is being leveraged from the company's own reference device including: biocompatibility (ISO 10993-10), design verification and process validation testing, user validation testing, packaging verification and shelf life testing, and physical properties testing by the material manufacturer.

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.

K212660

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.

K192596

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

February 24, 2022

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

Re: K211510

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 27, 2022 Received: January 31, 2022

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 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 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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K211510

Device Name uLab Systems Dental Aligner Kit

Indications for Use (Describe)

The uLab Systems Dental Aligner is indicated for the alignment of 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)

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510(k) Summary - K211510

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

Applicant Information:

uLab Systems, Inc. 1820 Gateway Drive Suite 300 San Mateo, CA 94404

Contact Person: Amir Abolfathi 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 Device:

Smylio Invisible Clear Aligners (Smylio, Inc.), K212660

Reference Device:

uLab Systems Dental Aligner Kit (uLab Systems, Inc.), K192596

Date Prepared:

February 22, 2022

Device Description:

Systems technology. The aligners are made of aesthetic and medical grade materials. 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 of 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 the same intended use for alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The subject and primary 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 orthodontictreatment of malocclusions by way of continuous gentle forces.
. Both devices have the same principle of operation.
Both devices are fabricated based on an orthodontic treatment plan designed from digital scans of the patient's teeth in an untreated state.
For both devices, the treatment plan is approved by the prescribing physician prior to manufacturing.
Both devices are made of thermoplastic.
. Treatment with both devices are monitored by the patient's dental health professional from placement of the first aligner through the delivery of the final aligner.

The only differences between the subject and predicate devices 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 materials as used in the reference device, whereas the predicate device materials are an unspecified thermoplastic.
. The indications for use for the subject device include the mode of action for correction of malocclusion: "by way of continuous gentle forces." The subject device does not include the words "permanent teeth" as compared to the reference device. However, this is in alignment with the Indications for Use for the primary predicate device.

Attribute	Subject Device	Primary Predicate	Reference Device
	uLab Systems Dental
Aligner Kit (uLab
Systems)	Smylio Invisible Clear
Aligners (Smylio, Inc.)
K212660	uLab Systems Dental
Aligner Kit (uLab
Systems) K192596
Indications
for Use	The uLab Systems Dental
Aligner is indicated for
the alignment of teeth
during orthodontic
treatment of
malocclusions by way of
continuous gentle forces.	The Smylio Invisible Clear
Aligners are indicated for
the alignment of teeth
during orthodontic
treatment of malocclusion.	The uLab Systems Dental
Aligner is indicated for the
alignment of permanent
teeth during orthodontic
treatment of malocclusions
by way of continuous
gentle forces.
Device
Description	A series of customized
removable clear plastic
orthodontic aligners that
sequentially position
teeth by way of
continuous gentle force.	A series of customized
removable clear plastic
orthodontic aligners that
sequentially position
teeth by way of
continuous gentle force.	A series of customized
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.	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	Standard dental
software, including 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	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	Standard dental software,
including 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
Attribute	Subject Device
uLab Systems Dental
Aligner Kit (uLab
Systems)	Primary Predicate
Smylio Invisible Clear
Aligners (Smylio, Inc.)
K212660	Reference Device
uLab Systems Dental
Aligner Kit (uLab
Systems) K192596
	plan, the software
converts the files to
produce the series of 3D
models used to produce
thermoformed aligners.	produce the series of 3D
models used to produce
thermoformed aligners.	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	Zendura A (thin
thermoformed
polyurethane) or Zendura
FLX (copolyester and
polyurethane composite)
Features	Aligners made from
different materials as
prescribed by physician	Aligners made from
different materials as
prescribed by physician for
daytime or nighttime use	Aligners made from
different materials as
prescribed by physician
OTC or Rx	Rx	Rx	Rx
Sterilization	No	No	No

Performance Data:

Conclusion:

The uLab Systems Dental Aligner Kit has the similar Indications for Use as the predicate device and identical technological characteristics as the company's own reference device. Performance data demonstrates that any differences in technological characteristics between the primary predicate device and subject device do not raise different questions of safety or effectiveness or are supported by the reference predicate. Therefore, the uLab Systems Dental Aligner Kit is substantially equivalent to the cleared predicate devices.