3M™ Clarity™ Aligners with Quick Attachments, is a clear plastic sequential aligner 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. 3M™ Clarity™ Aligners with Quick Attachments utilize the option of pre-formed and pre-cured attachments offering a more accurately shaped attachment. Attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement. 3M Clarity Aligners with Quick Attachments provide the option to form the attachments via an empty attachment template that is filled with adhesive and cured on the teeth or by pre-formed 3D printed custom attachments. The aligners, with or without attachments, are for orthodontic treatment of malocclusions.

AI/ML Overview

The provided document describes the 3M™ Clarity™ Aligners with Quick Attachments and its substantial equivalence to a predicate device, 3M™ Clarity™ Aligners (K231464).

Acceptance Criteria and Device Performance:

The document states that the proposed Quick Attachment alternative attachment delivery mechanism completed functional and performance testing, including but not limited to abrasion, bond strength, flexural strength, and stain resistance. The conclusion drawn is that the alternative Quick Attachment delivery mechanism does not impact the safety and effectiveness profile of the 3M™ Clarity™ Aligners and is substantially equivalent to the predicate device.

However, the document does not provide a specific table of acceptance criteria with numerical targets and the reported device performance against those targets. It only states that testing was performed and that the device met the safety and effectiveness profile.

Regarding the study that proves the device meets the acceptance criteria, the following information is available from the document:

This document summarizes a 510(k) premarket notification, which establishes substantial equivalence, implying that the new device is as safe and effective as a legally marketed predicate device. In this context, detailed "acceptance criteria" and "study results" in the format typically seen for a new drug or high-risk medical device might not be explicitly outlined with quantitative data in this summary. Instead, the focus is on demonstrating that the modifications (Quick Attachments) do not alter the safety and efficacy profile from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Maintenance of Safety and Effectiveness Profile of Predicate Device (3M™ Clarity™ Aligners)	The alternative Quick Attachment delivery mechanism does not impact the safety and effectiveness profile of the predicate device.
Acceptable Abrasion Resistance	Testing completed, considered acceptable.
Acceptable Bond Strength	Testing completed, considered acceptable.
Acceptable Flexural Strength	Testing completed, considered acceptable.
Acceptable Stain Resistance	Testing completed, considered acceptable.

Note: The specific numerical acceptance criteria and detailed quantitative results for abrasion, bond strength, flexural strength, and stain resistance are not provided in this 510(k) summary.

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

The document does not specify the sample size used for the functional and performance testing for the Quick Attachments. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The tests mentioned (abrasion, bond strength, flexural strength, stain resistance) are typically objective laboratory or mechanical tests rather than those requiring expert ground truth in a clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided in the document, as the tests described are objective performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical orthodontic product, and the testing described relates to its physical and material properties. There is no mention of an algorithm or AI component in this context.

7. Type of Ground Truth Used:

The "ground truth" for the functional and performance testing (abrasion, bond strength, flexural strength, stain resistance) would be the established scientific and engineering standards and methods for measuring these material properties. It is not an expert consensus, pathology, or outcomes data in the clinical sense for this type of device.

8. Sample Size for the Training Set:

Not applicable. The document describes functional and performance testing of a physical device component, not an AI or algorithm that would require a training set.

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

Not applicable, as there is no training set mentioned or implied for this device.

Summary

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September 29, 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: K233257

Trade/Device Name: 3M™ Clarity™Aligners with Ouick Attachments Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: September 28, 2023 Received: September 28, 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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).

Sincerelv.

Michael E. Adjodha -S

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K233257 KXXXXX

Device Name

3M™ Clarity TM Aligners with Quick Attachments

Indications for Use (Describe)

3M™ Clarity™ Aligners with Quick Attachments 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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510(k) #: KXXXX	K233257
510(k) Summary	Prepared on: 2023-09-27
	21 CFR 807.92(a)(1)
Contact Details
Applicant Name	3M Company, Unitek Orthodontic Products
Applicant Address	2510 Conway Avenue St.Paul MN 55144 United States
Applicant Contact Telephone	612-710-9847
Applicant Contact	Mrs. Hillary Peetsch
Applicant Contact Email	hpeetsch@mmm.com
Device Name
	21 CFR 807.92(a)(2)
Device Trade Name	3M™ Clarity™ Aligners with Quick Attachments
Common Name	Orthodontic plastic bracket
Classification Name	Aligner, Sequential
Regulation Number	872.5470
Product Code	NXC
Legally Marketed Predicate Devices
	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)
K231464	3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex
	Product Code
	NXC
Device Description Summary
	21 CFR 807.92(a)(4)
3M™ Clarity™ Aligners with Quick Attachments, is a clear plastic sequential aligner 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. 3M™ Clarity™ Aligners with Quick Attachments utilize the option of pre-formed and pre-cured attachments offering a more accurately shaped attachment. Attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement. 3M Clarity Aligners with Quick Attachments provide the option to form the attachments via an empty attachment template that is filled with adhesive and cured on the teeth or by pre-formed 3D printed custom attachments. The aligners, with or without attachments, are for orthodontic treatment of malocclusions.
Intended Use/Indications for Use
	21 CFR 807.92(a)(5)
3M™ Clarity™ Aligners with Quick Attachments are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Indications for Use Comparison
	21 CFR 807.92(a)(5)
Both predicate and subject device have the same indications for use.
Technological Comparison
	21 CFR 807.92(a)(6)
3M™ Clarity™ Aligners with Quick Attachments are substantially equivalent to the predicate device. 3M™ Clarity™ Aligners with Quick Attachments are comparable to previously cleared device, 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-

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Flex) (K231464) as they have the same indications for use, same manufacturing processes, same design, same device feature, software, and are considered substantially equivalent (21 CFR 807.100).

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The proposed Quick Attachment alternative attachment delivery mechanism completed functional and performance testing; such tests include but are not limited to: abrasion, bond strength, flexural strength, and stain resistance.

Not applicable

The performance testing showed the alternate Quick Attachment delivery mechanism does not impact the safety and effectiveness profile of the 3M™ Clarity™ Aligners-Force, 3M™ Clarity™Aligners-Flex and is 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.