3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force. 3M™ Clarity™ Aligners-Flex) 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. The present Premarket Submission is for the simplification in the number of formulations of the aligner material. This simplification allows for streamlined manufacturing processes so that both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be composed of the same material with differing flexibilities. The aligners will still be named 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex).

3M is offering a treatment plan with two different aligner flexibilities where the dental health professional will determine which degree of flexibility to use during the treatment plan. 3M Clarity Aligners-Flex is designed to be more flexible thereby increasing patient comfort and ease of insertion and removal. 3M Clarity Aligners-Force is designed to be more rigid increasing the force persistence. 3M will continue to offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.

A dental health professional (e.g., orthodontist or dentist), prescribes 3M™ Clarity™ Alieners (3MTM Clarity™ Aligners-Force, 3MTM Clarity™ Aligners-Flex) based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. 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. 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the 3M™ Clarity™ Aligners. The core purpose of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K211190) rather than to present a study proving the device meets specific acceptance criteria for clinical performance that would allow it to be used as a standalone diagnostic or screening tool.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing conducted to show that the new material formulation of the aligners does not negatively impact safety and effectiveness compared to the predicate device. The information provided heavily focuses on bench testing and biocompatibility rather than clinical efficacy studies.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria with numerical targets and corresponding device performance values in detail. Instead, it states that "All performance testing shows acceptable results for all tested samples." The acceptance is based on demonstrating that the subject device's performance is comparable or equivalent to the predicate device, especially considering the change in material.

Feature Assessed (Acceptance Criteria Implicitly: Comparable to Predicate)	Reported Device Performance
Translucency properties	Acceptable results
Abrasion resistance	Acceptable results
Formability	Acceptable results
Mechanical stability	Acceptable results
Dimensional stability	Acceptable results
Force persistence	Acceptable results
Fatigue cracking resistance	Acceptable results
Chemical staining resistance	Acceptable results
Transportation	Acceptable results
Use life	Acceptable results
Biocompatibility (various endpoints)	Safe for its intended use

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each type of performance testing (translucency, abrasion, etc.). It generally refers to "all tested samples" from "bench testing." The data provenance is internal to 3M™ Company, arising from their in vitro and ex vivo laboratory testing. This is retrospective data collected for regulatory submission purposes. There is no information about country of origin for the data that would be relevant to clinical studies in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not directly applicable in the context of this 510(k) submission, as it relates to clinical efficacy studies or diagnostic performance evaluations. The "ground truth" here is established by the accepted scientific and engineering principles for material and device performance testing. For biocompatibility, a "Diplomate of the American Board of Toxicology" assessed the safety.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a bench testing and material change submission, not focused on human interpretation of clinical data in a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for an orthodontic aligner device, not an AI-assisted diagnostic or imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not a software algorithm. While software is used in the manufacturing process, the submission does not present performance data for the software itself in a standalone context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing is based on established scientific and engineering standards for material properties and device functionality, often evaluated against the previous (predicate) device's performance, as well as relevant ISO standards (e.g., ISO 10993 for biocompatibility) and FDA guidance documents. For biocompatibility, the assessment by a board-certified toxicologist serves as the expert evaluation.

8. The Sample Size for the Training Set:

Not applicable. This submission focuses on a physical device and its material properties, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI algorithm.

Summary

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May 22, 2023

3M Company, Unitek Orthodontic Products % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K231464

Trade/Device Name: 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: May 19, 2023 Received: May 19, 2023

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

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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,

Michael E. Adjodha -S

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

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Indications for Use

Submission Number (if known)

K231464

Device Name

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ ClarityTM Aligners-Flex)

Indications for Use (Describe)

3M Clarity TM 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)

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3M™ Company Unitek Orthodontic Products Traditional 510(k) Premarket Notification 3M™ Clarity™ Aligners (Force and Flex)

510(k) Summary 3M™ Clarity™ Aligners (Flex and Force)

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3M™ Company Unitek Orthodontic Products

Traditional 510(k) Premarket Notification 3M™ Clarity™ Aligners (Force and Flex)

Image /page/4/Picture/2 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, red font. The letters are connected and slightly overlapping. The background is white.

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

Submitter Information

510(k) Submitter	3M CompanyUnitek Orthodontic Products2510 Conway AvenueSt. Paul, MN 55144Establishment Registration No.: 2110898
Primary Contact	Brittany RandolphRegulatory Affairsbrandolph@mmm.com
Secondary Contact	Kristin TotushekRegulatory Affairs ManagerPhone: (651) 285-4332ktotushek@mmm.com

Subject Device Information

Submission Date	09 May 2023
Proprietary Trade Name	3MTM ClarityTM 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

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Indications for Use:

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

Predicate Device:

Product Name	3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Manufacturer	3M CompanyUnitek Orthodontic Products2510 Conway AvenueSt. Paul, MN 55144
510(k) Number	K211190
Device Class	2

Description of Device:

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3M™ Company Unitek Orthodontic Products

when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

Technological Characteristics:

3MTM ClarityTM Aligners (3MTM Clarity™ Aligners-Force, 3M™ ClarityTM Aligners-Flex) and the previously cleared aligners, 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (K211190) technological characteristics are similar but not identical. They have the same design, device features, software, and manufacturing processes but the material is different. The subject device introduces a new material formulation but the simplification of the aligner material formulation does not impact the safety and effectiveness. Differences in technological characteristics of the subject device and the predicate device have been evaluated in accordance with the Agency's Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] dated July 28, 2014. Differences in the technological characteristics do not raise significant concerns about safety or effectiveness.

Substantial Equivalence – Intended/Indicated Use, Technological Characteristics
Feature	Predicate Device:3M™ Clarity™ Aligners (3M™Clarity™ Aligners-Force, 3M™Clarity™ Aligners-Flex)	Subject Device:3M™ Clarity™ Aligners (3M™Clarity™ Aligners-Force, 3M™Clarity™ Aligners-Flex)
Manufacturer	3M CompanyUnitek Orthodontic Products2510 Conway AvenueSt. Paul, MN 55144	No change
510(k) Number	K211190	To be determined
RegulationNumber	21 CFR 872.5470	No change
Product Code	NXC	No change
Device Class	Class II	No change
Intended Use:	This product is intended for use inorthodontic treatment.	No change
Indications forUse:	3M Clarity Aligners are indicated forthe alignment of teeth duringorthodontic treatment ofmalocclusion.	No change
ManufacturingProcess	Aligners are manufactured using athermoform process.	No change

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Substantial Equivalence – Intended/Indicated Use, Technological Characteristics
Feature	Predicate Device:3M™ Clarity™ Aligners (3M™Clarity™ Aligners-Force, 3M™Clarity™ Aligners-Flex)	Subject Device:3M™ Clarity™ Aligners (3M™Clarity™ Aligners-Force, 3M™Clarity™ Aligners-Flex)
Material	Two Copolyesters	CopolyesterPoly CyclohexylenedimethyleneTerephthalate Glycol-Modified(PCTG)
TechnicalFeatures andProperties	Orthodontic tooth movements occurthrough forces applied to thedentition as each tooth follows theprogrammed displacement based on adoctor's prescription.	No change
Software	Proprietary software is used in themanufacturing process of thecurrently commercialized aligners.	No change

Performance Testing:

Results of translucency properties, abrasion resistance, formability, mechanical stability, dimensional stability, force persistence, fatigue cracking resistance, chemical staining resistance, transportation, and use life testing among others are included in this Premarket submission. All performance testing shows acceptable results for all tested samples.

Software

There are no significant changes in the software used to prepare treatment plans or produce trays compared to the predicate device, 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex).

Biocompatibility Testing

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) were assessed as a mucosal membrane contacting device that is intended to be in contact with the body for greater than 30 days.

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MTM Company Jnitek Orthodontic Products

Traditional 510(k) Premarket Notification 3MTM ClarityTM Aligners (Force and Flex)

In accordance with the combined guidance found in ISO 10993, ISO 7405, Testing guidelines outlined in the US FDA Docket Number FDA-2013-D-0350, and Japan: PSEHB/MDED No. 0106-1 and 0612-4, the following endpoints below must be considered in the biocompatibility evaluation of this product: Physical and/or Chemical Information, Cytotoxicity, Sensitization, rritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Sub-acute Toxicity, Sub-chronic Toxicity, Genotoxicity, Implantation, and Chronic Toxicity.

A Diplomate of the American Board of Toxicology has assessed the safety of this product and nas determined that it is safe for its intended use.

Substantial Equivalence

Substantial equivalency of the subject device, 3M™ Clarity™ Aligners (3MTM Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) to the predicate device, 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) is made on the basis of intended/indicated use, technological characteristics, and performance testing. The subject device and the predicate device are similar in that they have:

same intended use. ●
same indications for use, ●
same design and device features
same manufacturing software
same manufacturing processes ●
similar technological characteristics

The differences in the technological characteristics between the subject device and predicate device do not raise different questions of safety or efficacy. Therefore, the subject device is ound to be substantially equivalent to the legally marketed predicate device, 3M™ Clarity™ ligners (3MTM ClarityTM Aligners-Force, 3MTM Clarity™ Aligners-Flex) (K211190).

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Conclusion:

The indications for use of 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) are the same as the previously cleared device, 3M™ Clarity™ Aligners (3MTM Clarity™ Aligners-Force, 3MTM Clarity™ Aligners-Flex) (K211190). Both devices are rthodontic clear tray aligners with a multi-layer film construction. The subject devices echnological characteristics are similar but not identical to the predicate device.

ifferences in technological characteristics of the subject device and the predicate device has een evaluated in accordance with the Agency's Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] dated July 28, 2014. Differences in the technological characteristics do not raise significant concerns about safety or effectiveness. Bench testing was conducted to compare the performance of 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ ClarityTM Aligners-Flex) to the previously cleared device, 3M™ Clarity™ Aligners (3MTM Clarity™ ligners-Force, 3M™ Clarity™ Aligners-Flex) (K211190). Testing demonstrates that the safety nd performance of the subject device are substantially equivalent to the predicate device.

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.