(1 days)
Not Found
No
The summary describes a physical medical device (clear aligners and attachments) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the alignment of teeth during orthodontic treatment of malocclusion, which is a therapeutic purpose.
No
The device is described as a "clear plastic sequential aligner" used for "alignment of teeth during orthodontic treatment of malocclusion." Its purpose is to correct tooth malocclusions, not to diagnose them.
No
The device description clearly states it is a "clear plastic sequential aligner" and mentions "pre-formed and pre-cured attachments" and "3D printed custom attachments," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 3M™ Clarity™ Aligners with Quick Attachments are physical devices used to mechanically move teeth for orthodontic treatment. They are applied directly to the teeth and do not involve testing samples from the body.
- Intended Use: The intended use is "alignment of teeth during orthodontic treatment of malocclusion," which is a mechanical process, not a diagnostic one.
- Device Description: The description details a "clear plastic sequential aligner" and "attachments" that apply force to teeth. This aligns with a physical treatment device, not a diagnostic test.
Therefore, the function and purpose of this device clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
3M™ Clarity™ Aligners with Quick Attachments are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
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.
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
Not Found
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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.
1
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
2
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)
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."
3
| 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- |
4
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.