The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.

Device Description

Clear Moves Aligners are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a dental device called "Clear Moves Aligners." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on comparisons to existing devices and bench testing, rather than detailed human clinical study data with specific acceptance criteria, expert ground truth, or MRMC studies that would be typical for more novel or higher-risk medical devices.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device itself (e.g., accuracy of tooth movement in millimeters). Instead, the "performance" described is about demonstrating that the manufacturing process is valid and the materials are biocompatible, and that the device is "substantially equivalent" to predicate devices.

Acceptance Criteria (Implied for Substantial Equivalence and Safety)	Reported Device Performance (from the document)
Biocompatibility: Device materials must be biocompatible.	Biocompatibility: "Testing of the plastic thermoformable materials used to make these aligners have been provided in previous 510(k) submissions to FDA. The Reference 510(k) is included because it was submitted for the copolyester material to be used for fabrication of many oral appliances using thermoforming processes." "Yes, shown to meet requirements" in the SE Comparison Table.
Manufacturing Process Validation: The manufacturing process must ensure accuracy of the final thermoformed aligner compared to the initial digital scan.	Manufacturing Process Validation: "Bench testing was performed of each aligner thermoplastic material to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan. A final report was part of the 510(k) package." "Yes, performed" in the SE Comparison Table.
Equivalence in Intended Use: The device must have the same intended use as the predicate devices.	Equivalence in Intended Use: "The Clear Moves Aligner has the same intended use as the predicate devices." (Confirmed in Indications for Use vs. Predicates table).
Equivalence in Material: The thermoplastic materials used must be the same as or comparable to those in predicate devices.	Equivalence in Material: "The thermoplastic materials used for the manufacture of the Clear Moves Aligers are the same materials used to make the predicate aligners." (Detailed in Material row of SE Comparison Table).
Equivalence in Design/Technology: The design phase and software used must be the same as or comparable to those in predicate devices.	Equivalence in Design/Technology: "The design phase makes the use of the same software as the Predicates." "The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (Reference device - K180941). It also is the same as used for the Predicates."
Equivalence in Manufacturing Fabrication: The manufacturing fabrication process must be similar to industry-standard processes used for predicate devices.	Equivalence in Manufacturing Fabrication: "The manufacturing fabrication of the clear aligner makes use of similar, industry-standard processes with the similar machines and materials. Any differences in the specific company processes do not raise new questions of safety and effectiveness." (Detailed in Manufacturing Process row of SE Comparison Table).

2. Sample sizes used for the test set and the data provenance

The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category." Therefore, there is no test set of clinical patient data in the traditional sense, for which sample sizes or data provenance (country, retrospective/prospective) would be applicable concerning the device's clinical performance. The "test sets" mentioned would be for biocompatibility testing (material samples) and mechanical bench testing (prototype aligners/molds). These details are not provided in terms of specific sample numbers or origins within this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no human clinical performance testing was required or conducted for this 510(k) submission, there was no "ground truth" derived from expert consensus on patient outcomes/diagnoses related to the device's effectiveness. Ground truth for bench testing would typically involve engineering specifications or physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

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 device is a physical orthodontic aligner, not an AI-powered diagnostic or assistive tool. While software is used for treatment planning, the submission focuses on the aligner itself and does not include an MRMC study comparing human performance with and without AI assistance.

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

Not applicable. This is not an AI algorithm being submitted for standalone performance. The software mentioned (Ortho Analyzer) is a pre-existing, referenced device used for treatment planning, not for autonomous diagnosis or treatment execution.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the compliance requirements:

Biocompatibility: Ground truth would be established by validated test methods (e.g., ISO standards) and comparison to known safe materials.
Manufacturing Process Validation: Ground truth would be established by engineering specifications, CAD models, and precise measurements comparing the manufactured parts to the digital design.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" for an algorithm to learn from data.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI algorithm was used.

Summary

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August 1, 2024

Clear Moves Aligners % Patsy Trisler Regulatory Consultant Trisler Consulting 306 Turnberry Court Lebanon, Indiana 46052

Re: K241137

Trade/Device Name: Clear Moves Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 23, 2024 Received: April 24, 2024

Dear Patsy Trisler:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241137

Device Name

Clear Moves Aligner

Indications for Use (Describe)

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.

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Submitter: Clear Moves Aligners

Clear Moves Aligners K241137 Traditional Premarket Notification 510(k)

SUBMITTER Name:	Clear Moves Aligners
Address:	100 Jade Block, Park View CityRiver Edge Housing SchemeLahore, Pakistan 54000
Contact Person:	Muhammad Awais
Email:	Mawais2487@gmail.com
Date Prepared:	June 25, 2024
DEVICE TradeName:	Clear Moves Aligners
Common Name:	Aligner, Sequential (Clear Braces)
Classification Name	Orthodontic Plastic Bracket
Number	21 CFR 872.5470
Product Code	NXC
Regulatory Class	2
Review Panel	Dental
PREDICATE /REFERENCEDEVICES	Predicate #1: K210540, Ohlendorf Appliance Laboratory:Ohlendorf Clear AlignerPredicate #2: K221097, Ordont Orthodontic Laboratories, Inc.:SmileSeriesReference Device: K062828, Dentsply Sirona: DentsplyMouthguard and Aligner Materials
DEVICEDESCRIPTION	Clear Moves Aligners are comprised of a series of clear, thin,thermoformed removable aligner trays that are designed tocorrect tooth malocclusions without the use of conventionalwire and bracket orthodontic technology. They are made ofbiocompatible thermoformable plastics, either from acopolyester or a composite of copolyester and polyurethane.They are provided non-sterile and are customized for eachpatient according to the dental clinician's prescription.The dental health professional (dentist/orthodontist) providesphysical or scanned impressions of the patient's teeth to ClearMoves Aligners. A treatment plan using commercially availabletreatment planning software of either the scanned impression ora scan of the physical impression is sent to the clinician forapproval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed onthe molds and laser marked with patient identifying informationand treatment step.The finished, customized aligners are provided to the dentalhealth care professional who provides them to the patient,confirming fit and design. The aligner trays are held in place bypressure and can be removed by the patients at any time.
MECHANISM OFACTION	Each aligner in the set is used for the specified period of time,usually 2-3 weeks, to exert gentle force to achieve progressiverealignment of the teeth until the final correction has beenachieved. The daily treatment time is approximately 22 hours
or except during eating, based on the clinician's prescribedtreatment plan.
SUMMARY OFTECHNOLOGICALCHARACTERISTICS	The thermoplastic materials used for the manufacture of theClear Moves Aligers are the same materials used to make thepredicate aligners.The software system used is Ortho Analyzer, 2019 ver 1.8.1.0by 3Shape A/S (Reference device - K180941). It also is thesame as used for the Predicates. It is used for management of3D scanned orthodontic models, orthodontic diagnosis bymeasuring, analyzing, inspecting and visualizing 3D scannedorthodontic models, virtual planning of orthodontic treatmentsby simulating tooth movements, and design of orthodonticappliances based on 3D scanned orthodontic models.
INDICATIONS FORUSE STATEMENT	The Clear Moves Aligner is a series of clear, lightweight, plasticappliances indicated for the correction of dental malocclusion inadult and adolescent patients with permanent dentition (i.e. allsecond molars). Clear Moves Aligner positions teeth by way ofcontinuous gentle force.
SAFETY TESTING	Biocompatibility: Testing of the plastic thermoformablematerials used to make these aligners have been provided inprevious 510(k) submissions to FDA. The Reference 510(k) isincluded because it was submitted for the copolyester materialto be used for fabrication of many oral appliances usingthermoforming processes.
PERFORMANCETESTING	Bench testing was performed of each aligner thermoplasticmaterial to validate the manufacturing process, to ensure theaccuracy of the final thermoformed aligner compared to theinitial digital scan. A final report was part of the 510(k) package.In vivo Animal and Human Clinical performance testing are notrequired for this device category.
COMPARISON TOTHE PREDICATEDEVICE	The Clear Moves Aligner has the same intended use as thepredicate devices. The thermoplastic materials are the sameand the design phase makes the use of the same software asthe predicates. The manufacturing fabrication of the clearaligner makes use of similar, industry-standard processes withthe similar machines and materials. Any differences in thespecific company processes do not raise new questions ofsafety and effectiveness.
SUBSTANTIALEQUIVALENCECONCLUSION	The information and data provided in this 510(k) establish thatthe Clear Moves Aligner is substantially equivalent to thepredicate devices in the intended use, design, principle ofoperation, technology, including the thermoformable materialsused to make the aligners. See the following SE Comparisontable.

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Substantial Equivalence Comparison Table
510(k) Number	Proposed DeviceK241137	Predicate #1K210540	Predicate #2K221097
Device Name	Clear Moves Aligners	Ohlendorf Clear Aligner	Ordont SmileSeries
Manufacturer	Clear Moves Aligners	Ohlendorf ApplianceLaboratory	Ordont OrthodonticLaboratories, Inc.
ClassificationRegulationNameProduct CodeClass	21 CFR 872.5470Orthodontic PlasticBracketNXC2	21 CFR 872.5470Orthodontic PlasticBracketNXC2	21 CFR 872.5470Orthodontic PlasticBracketNXC2
Indications forUse	The Clear Moves Aligneris a series of clear,lightweight, plasticappliances indicated forthe correction of dentalmalocclusion in patientswith permanent dentition(i.e. all second molars).Clear Moves Alignerpositions teeth by way ofcontinuous gentle force.	... indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion in patientswith permanent dentition(i.e. all second molars)....positions teeth by wayof continuous gentleforce.	... indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion in patientswith permanent dentition(i.e. all second molars)....positions teeth by wayof continuous gentleforce.
Mode ofAction	The removable applianceapplies gentle forces onteeth according to the planprescribed by the doctor.	same	same
Description ofUse	Each removablepreformed plastic tray,prescribed by the Dr, isworn by the patient usuallyfor a couple weeks, priorto using the nextsequential aligner tray.	same	same
Material	Thermoformed copolyesteror polyurethane/copolyester composite	Thermoformedpolyurethane/copolyestercomposite	Thermoformedcopolyester
ManufacturingProcess	Forming of plastic sheetson unique dental modelsusing thermoformingmachine	same	same
Software Used	Yes, for treatmentplanning and 3D printing ofmodels.	same	same
PrescriptionUse	Rx	Same	Same
Biocompatibility	Yes, shown to meetrequirements	Same	Same
ProcessValidation	Yes, performed	Same	Same

Substantial Equivalence Comparison Table

Testing |

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.