Who is the manufacturer of ClearPath Aligner?

Clearpath Orthodontics, Ltd. filed the 510(k) submission for ClearPath Aligner (K202857).

What is the FDA product code for ClearPath Aligner?

NXC. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ClearPath Aligner?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ClearPath Aligner?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ClearPath Aligner

K202857 · Clearpath Orthodontics, Ltd. · NXC · Jan 5, 2021 · Dental

Device Facts

Record ID	K202857
Device Name	ClearPath Aligner
Applicant	Clearpath Orthodontics, Ltd.
Product Code	NXC · Dental
Decision Date	Jan 5, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The ClearPath 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). The ClearPath Aligner positions teeth by way of continuous gentle force.

Device Story

ClearPath Aligner consists of series of clear, thermoformed, removable plastic trays designed to correct dental malocclusion. Clinician provides physical or scanned impressions; ClearPath uses Ortho Analyzer software (3Shape A/S) to create digital setup for clinician approval. Approved designs are 3D-printed into molds; aligners are thermoformed over molds and laser-marked. Device is used in dental clinic; operated by dentist/orthodontist; worn by patient 22 hours/day. Each tray exerts continuous gentle force for 2-3 weeks to achieve progressive tooth realignment. Output is physical aligner tray; clinician confirms fit and design. Benefits include non-invasive, removable orthodontic correction without conventional wires/brackets.

Clinical Evidence

Bench testing only. Validation performed to ensure accuracy of final thermoformed aligner compared to initial digital scan. Biocompatibility testing (ISO 10993-5 Cytotoxicity) provided for finished thermoformed aligner. No clinical or animal data required.

Technological Characteristics

Thermoformed plastic aligner trays; non-sterile. 3D-printed molds. Software: Ortho Analyzer 2019 ver 1.8.1.0 (3Shape A/S) for 3D model management, diagnosis, virtual treatment planning, and appliance design. Laser-marked. Connectivity: digital file transfer for planning.

Indications for Use

Indicated for correction of dental malocclusion in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

ClearPath Aligner (K162609)

Reference Devices

Ortho System™, 3Shape A/S (K180941)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. January 5, 2021 ClearPath Orthodontics Ltd % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250 Re: K202857 Trade/Device Name: ClearPath Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 25, 2020 Received: September 28, 2020 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 (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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202857 Device Name ClearPath Aligner Indications for Use (Describe) The ClearPath 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). The ClearPath Aligner positions teeth by way of continuous gentle force. 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) | |----------------------------------------------------------------------------------------------|---------------------------------------------| | <div> </div> | | 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}------------------------------------------------ ## K202857 # 510(k) SUMMARY | SUBMITTER | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name: | ClearPath Orthodontics, Ltd | | Submitter Address: | 6-N Main Boulevard Johar Town Lahore-Pakistan, 54000 | | Contact Person: | Dr. Waqas Wahab, Chief Executive Officer | | Email: | Waqas.wahab@clearpathortho.com | | Telephone: | +92 322 491 33 77 | | Date Prepared: | September 25, 2020 | | DEVICE | | | Device Trade Name: | ClearPath Aligner | | Common Name: | Aligner, Sequential (Clear Braces) | | Classification Name Number | Orthodontic Plastic Bracket 21 CFR 872.5470 | | Product Code | NXC | | Regulatory Class | 2 | | Review Panel | Dental | | PREDICATE DEVICE | Primary Predicate: K162609, ClearPath Aligner, ClearPath Orthodontics Reference Device: K180941 Ortho System™, 3Shape A/S | | DEVICE DESCRIPTION | The ClearPath clear aligner is 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. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup 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. 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. | | MECHANISM OF ACTION | Based on a clinician's prescribed treatment plan, each aligner in the set is used for the specified period of time to exert gentle force to achieve progressive realignment of the teeth until the final correction has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patient for 22 hours per day. | | SUMMARY OF TECHNOLOGICAL CHARACTERISTICS | The thermoplastic materials used for the manufacture of the ClearPath aligner is the same material used to make the predicate ClearPath Aligner. | | | The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (Reference device - K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. | | INDICATIONS FOR USE STATEMENT | The ClearPath 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). The ClearPath Aligner positions teeth by way of continuous gentle force. | | SAFETY TESTING | Biocompatibility: Testing of the plastic thermoformable material used to make the ClearPath Aligner has been provided to FDA previously. | | | ISO 10993-5 Cytotoxicity Testing of the finished thermoformed aligner was provided. | | PERFORMANCE TESTING | Bench testing was performed to validate the manufacturing process: to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan. | | | In vivo Animal and Human Clinical performance testing are not required for this device category. | | COMPARISON TO THE PREDICATE DEVICE | The ClearPath Aligner has the same intended use as the predicate device. There are no fundamental technological differences between the Predicate and the modified device. The difference between the new and predicate devices is in the use of the referenced software during specified steps in the manufacturing process. | | SUBSTANTIAL EQUIVALENCE CONCLUSION | The information and data provided in this 510(k) establish that the ClearPath Aligner is substantially equivalent to the predicate ClearPath Aligner in the intended use, design, principle of operation, technology, and thermoformable material used to make the aligner. Comparison of all key parameters are presented in the following SE Comparison table | {4}------------------------------------------------ {5}------------------------------------------------ | | Proposed Device | Predicate Device K162609 | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | ClearPath Aligner | ClearPath Aligner | | Manufacturer | ClearPath Orthodontics, Ltd | ClearPath Orthodontics, Ltd | | Classification Regulation Name Product Code Class | 21 CFR 872.5470 Orthodontic Plastic Bracket NXC 2 | 21 CFR 872.5470 Orthodontic Plastic Bracket NXC 2 | | Indications for Use | The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in adult and adolescent patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force. | The ClearPath 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). The ClearPath Aligner positions teeth by way of continuous gentle force. | | Mode of Action | The appliance applies gentle forces on teeth according to the plan prescribed by the doctor. | The appliance applies gentle forces on teeth according to the plan prescribed by the doctor. | | Description of Use | Each removable preformed plastic tray is worn by the patient as prescribed by the doctor, usually a few weeks prior to using the next sequential aligner tray. | Each removable preformed plastic tray is worn by the patient as prescribed by the doctor, usually a few weeks prior to using the next sequential aligner tray. | | Material | Thermoformed plastic | Thermoformed plastic | | Software Used | Yes, for treatment planning and 3D printing of models. | No | | Prescription Use | Rx | Rx | | Biocompatibility | Yes, shown to meet requirements | Yes, shown to meet requirements | | Validation Testing | Yes, performed | Yes, performed. | ## Substantial Equivalence Comparison Table

ClearPath Aligner

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Device Story

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