K Number

Device Name

3M Clarity Aligners

Manufacturer

3M Company

Date Cleared

2019-09-05

(30 days)

Product Code

NXC

Regulation Number

872.5470

Intended Use

3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion

Device Description

The 3M Clarity Aligners are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes 3M Clarity Aligners based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. There are no changes being made to the 3M Clarity Aligners themselves. Both the proposed 3M Clarity Aligners and the primary predicate 3M Clarity Aligners (K183159) have the same indications for use. The present premarket submission is to account for the overall software cumulative changes including the integration of the ULab software (K171295).

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

K183159

Reference Devices

K171295

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard dental software for tooth alignment and the integration of existing software (ULab K171295), with no mention of AI or ML in the device description or the "Mentions AI, DNN, or ML" section.

Therapeutic

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

Diagnostic

The 3M Clarity Aligners are used for the alignment of teeth, which is a treatment, not a diagnostic, function. The diagnostic assessment of the patient's teeth is performed by a dental health professional.

SaMD (Software as a Medical Device)

The device description clearly states that the device is a series of clear plastic aligners, which are physical objects. While software is used in the design and planning process, the final medical device delivered to the patient is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, the 3M™ Clarity™ Aligners are not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
3M Clarity Aligners Function: The 3M Clarity Aligners are a physical device used to mechanically move teeth for orthodontic treatment. They are based on physical molds or scans of the patient's teeth and a treatment plan determined by a dental professional. They do not analyze biological specimens.
Intended Use: The intended use is for "alignment of teeth during orthodontic treatment of malocclusion," which is a mechanical and structural correction, not a diagnostic test.
Device Description: The description clearly outlines a process of creating physical aligners based on patient anatomy and a treatment plan, not a process of analyzing biological samples.

Therefore, the 3M Clarity Aligners fall under the category of a medical device used for treatment, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

3M Clarity Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Product codes

NXC

Device Description

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes 3M Clarity Aligners based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental health professional (e.g. orthodontist or dentist)

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)

Results of verification and validation testing demonstrate the proposed 3M Clarity Aligners showed conformity with pre-established specifications and acceptance criteria. Software testing was conducted in accordance with "General Principles of Software Validation; Final Guidance for Industry and FDA Staff'' dated January 11, 2002 and Medical Device Software - Software Life Cycle Processes; ANSI/AAMI/IEC 62304:2015.

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

Not Found

Predicate Device(s)

K183159

Reference Device(s)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 5, 2019

3M Company % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K192119

Trade/Device Name: 3M Clarity Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: August 5, 2019 Received: August 6, 2019

Dear Prithul Bom:

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 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 Michael Adjodha Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2020 See PRA Statement below.

510(k) Number (if known)
--------------------------	--

K192119

Device Name

3Mm Clarity TM Aligners

Indications for Use (Describe)

3MM Clarity Aligners are indicated for the alignment of teeth during orthodontic treatment of 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

510(k) Summary

K192119

C. N

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Submitter | 3M Company
2510 Conway Avenue
St. Paul, MN 55144
Owner/Operator No.: 2110898
Establishment Registration No.: 2110898 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Yanine Garcia-Quezada
Regulatory Affairs
Phone: (651) 736-8238
Fax: (651) 736-1599
ygarcia-quezada@mmm.com |
| Secondary Contact | Mark Burville
Regulatory Affairs Manager
Phone: (651) 737-2027
Fax: (952) 918-5242
mcburville@mmm.com |
| Submission Date | 24 May 2019 |
| Proprietary Trade Name | 3M™ Clarity™ Aligners |
| Device Name | Aligner |
| Common Name | Sequential Aligner |
| Classification Name | Orthodontic Plastic Bracket |
| Regulation Number | 21 CFR 872.5470 |
| Product Code | NXC |
| Classification Panel | Dental Products Panel 76 |
| Classification | Medical Device Class II |

Indications for Use:

3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Predicate Devices:

3M Clarity Aligners (K183159) [Primary Predicate Device]

Description of Device:

There are no changes being made to the 3M Clarity Aligners themselves. Both the proposed 3M Clarity Aligners and the primary predicate 3M Clarity Aligners (K183159) have the same

indications for use. The present premarket submission is to account for the overall software cumulative changes including the integration of the ULab software (K171295).

Technological Characteristics:

The modified 3M Clarity Aligners and the previously cleared 3M Clarity Aligners (K183159) have the same technological characteristics, such as design, material composition, device features, as well as their manufacturing processes.

Performance Testing:

Substantial Equivalence Comparison
------------------------------------	--

	Primary Predicate Device:	Proposed Device:	Comparison:
	3MTM ClarityTM Aligners
(K183159)	3MTM ClarityTM Aligners
Indications
for Use	3M Clarity Aligners are
indicated for the alignment of
teeth during orthodontic
treatment of malocclusion	3M Clarity Aligners are indicated
for the alignment of teeth during
orthodontic treatment of
malocclusion	Identical
Software
Description	The Oral Care Portal implements
3M Clarity Aligners ordering
and review/approval process.
Doctors may submit orders
through the Order Wizard. The
model is then manipulated
outside of the system for the
final occlusion based on the
characteristics in the submitted
order. This setup model is sent
back to the system for the doctor
to review, and subsequently
approved or rejected. If the
doctor rejects the model, the
process is repeated until the
doctor approves the model.	The Oral Care Portal implements
3M Clarity Aligners ordering and
review/approval process. Doctors
may submit orders through the
Order Wizard. The model is then
manipulated outside of the system
for the final occlusion based on
the characteristics in the
submitted order. This setup
model is sent back to the system
for the doctor to review, and
subsequently approved or
rejected. If the doctor rejects the
model, the process is repeated
until the doctor approves the
model.	Identical
Mode of
Operation	Oral Care Portal software
performs the following
operations:
-Produce 3D model file of a
digital scan or from a PVS
impression model
-Identifies individual teeth that
will require treatment
-Creates a treatment plan
-Communicates with Dental
Health Professional where
treatment plan is reviewed, if
modifications are requested
these are applied prior to
approval.	Oral Care Portal software
performs the following
operations:
-Produce 3D model file of a
digital scan or from a PVS
impression model
-Identifies individual teeth that
will require treatment
-Creates a treatment plan
-Communicates with Dental
Health Professional where
treatment plan is reviewed, if
modifications are requested these
are applied prior to approval.	Identical
Software
Elements	An electronic description form
and process used to depict, edit,
view, monitor and approve an
orthodontic treatment plan	An electronic description form
and process used to depict, edit,
view, monitor and approve an
orthodontic treatment plan	Identical
	Treatment Plan:	Treatment Plan:	Identical
Software Elements	-Dental Health Professional
accesses 3M OCP web-based
application
-Treatment plan is created and
submitted to 3M	-Dental Health Professional
accesses 3M OCP web-based
application
-Treatment plan is created and
submitted to 3M
Software
Elements-
ULab	Set Up Record Treatment Plan:
-Dental Health Professional
accesses 3M OCP web-based
application and finds ULab icon
-Dental Health Professional
signs into ULab software
-Treatment plan is created and
submitted to 3M
-3M creates treatment plan based
on ULab setup record
-3M and Dental Health
Professional interact until design
treatment is approved	Full Treatment Plan:
-Dental Health Professional
accesses 3M OCP web-based
application and finds ULab icon
-Dental Health Professional signs
into ULab software
-Treatment plan is created and
submitted to 3M
-3M manufactures aligners
Note: there are no records QC or
setup review steps in the process.
The order goes directly to
production software	Proposed software includes
ULab treatment plan that
eliminates the interaction
with 3M technicians. The
Dental Health Professional
owns the treatment
planning process and
submits directly to 3M for
manufacturing
Note: both ULab Set Up
Record and Full Treatment
plans are available. The
Dental Health Professional
chooses which ULab plan
to use

Substantial Equivalence Conclusion:

The 3M Clarity Aligners are substantially equivalent to the primary predicate device (21 CFR 807.100). The 3M Clarity Aligners are identical in all aspects to the primary predicate, other than software improvements and the integration of the ULab software. 3M Clarity Aligners are as safe, as effective, and substantially equivalent to the predicate device in terms of intended use, indications for use, design, performance, technological characteristics, mechanism of action, composition and biocompatibility.