Who is the manufacturer of ClearCorrect System?

Clearcorrect, LLC filed the 510(k) submission for ClearCorrect System (K220140).

What is the FDA product code for ClearCorrect System?

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

What is the regulatory pathway for ClearCorrect System?

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

Who can help prepare an FDA 510(k) submission like ClearCorrect System?

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.

ClearCorrect System

K220140 · Clearcorrect, LLC · NXC · Oct 5, 2022 · Dental

Device Facts

Record ID	K220140
Device Name	ClearCorrect System
Applicant	Clearcorrect, LLC
Product Code	NXC · Dental
Decision Date	Oct 5, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.

Device Story

ClearCorrect System consists of sequential clear thermoformed orthodontic aligners; used intra-orally by patients 20–22 hours/day for 1–3 weeks per aligner. Aligners apply corrective forces based on difference between starting and planned tooth positions; composite resin attachments may be added to improve retention or force application. Treatment planning involves ClearCorrect technicians using 'Cut and Stage' software to process PVS impressions or intra-oral scans; software interprets intermediate tooth states based on clinician instructions and defined motion limits. Clinicians use 'Doctor Portal' to submit cases and 'ClearPilot' to review, comment, approve treatment plans, and monitor progress. System benefits patients by progressively repositioning teeth to correct malocclusion.

Clinical Evidence

Bench testing only. Performance data includes package integrity (ISTA 2A), shelf life (ASTM F1980), biocompatibility (ISO 10993), water absorption (ISO 62), tensile performance (ISO 527-3), flexural performance (ISO 178), impact performance (ISO 8256), tear resistance (ISO 6383-1), fatigue resistance (ASTM D7774), stress relaxation, dimensional stability, usability (IEC 62366-1), and software development (IEC 62304).

Technological Characteristics

Aligners made of multi-layer polymer film (ClearQuartz): one layer elastomeric polyurethane between two layers of rigid co-polyester. Non-sterile, single-patient use. Software-driven treatment planning and fabrication. Connectivity via Doctor Portal/ClearPilot web-based interfaces. Standards: ISO 10993, ISO 62, ISO 527-3, ISO 178, ISO 8256, ISO 6383-1, ASTM D7774, ASTM F1980, IEC 62366-1, IEC 62304.

Indications for Use

Indicated for alignment of teeth during orthodontic treatment of tooth malocclusion.

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

Invisalign System (K143630)

Reference Devices

ClearCorrect System (K210320)
Spark Clear Aligner System (K203737)

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. October 5, 2022 ClearCorrect, LLC Christopher Klaczyk VP, Head of Regulatory Affairs 21 Cypress Boulevard, Suite 1010 Round Rock, Texas 78665 Re: K220140 Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 8, 2022 Received: September 9, 2022 Dear Christopher Klaczyk: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220140 Device Name ClearCorrect System Indications for Use (Describe) The Clear Correct System is indicated for the alignment of teeth during orthodontic treatment of tooth 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) Summary | K220140 | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | ClearCorrect, LLC 21 Cypress Boulevard Suite 1010 Round Rock, TX 78665 | | Contact Person: | Christopher Klaczyk Head of Regulatory Affairs +1 (512) 831-5128 christopher.klaczyk@clearcorrect.com | | Date Prepared: | October 1, 2022 | | Product Code(s): | NXC (21 CFR 872.5470) | | Device Class: | II (21 CFR 872.5470) | | Classification Panel: | Dental Devices (DHT1B) | | Classification Name: | Orthodontic plastic bracket (21 CFR 872.5470) | | Common Name | Aligner, Sequential | | Proprietary Name: | ClearCorrect System | | Predicate Device(s): | K143630, Invisalign System, Align Technologies | | Reference Device(s): | K210320, ClearCorrect System, ClearCorrect, LLC K203737, Spark Clear Aligner System, Ormco Corporation | | Device Description: | The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks. The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the appliance. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force s in directions that cannot be achieved by engaging with tooth surfaces alone. | | Indications For Use: | The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion. | | Materials: | The ClearCorrect aligners are produced from multi-layer polymer film having the trade name ClearQuartz™. The film consists of one layer of elastomeric polyurethane sandwiched between two layers of rigid co-polyester. | | Technological Characteristics: | A comparison of the indications and relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows. | | Performance Data: | Package integrity via simulated transport test per ISTA 2A Validation of shelf life per ASTM F1980 Biocompatibility per the ISO 10993 series standards Water absorption testing per ISO 62 Tensile performance testing per ISO 527-3 Flexural performance testing per ISO 178 Impact performance testing per ISO 8256 Tear resistance testing per ISO 6383-1 Fatigue resistance testing per ASTM D7774 Stress relaxation testing Dimensional stability per internal methods Usability testing per IEC 62366-1 Software development per IEC 62304 | | Conclusions: | The Indications for Use and the technological characteristics of the subject device are largely the same as the primary predicate device. The material of construction and the treatment planning software are identical to the reference predicate device. The subject devices have been determined to be substantially equivalent to the identified predicate devices. | {4}------------------------------------------------ {5}------------------------------------------------ | Feature | Subject Device ClearCorrect System | Primary Predicate Device Invisalign System (K143630) | Reference Device ClearCorrect System (K210320) | Reference Device Spark Clear Aligner Sys. (K203737) | Equivalence Discussion | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion. | The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. | The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force. | The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. | Equivalent The indication for the Subject Device is a subset of the indications for the Primary Predicate Device. And the K203737 Reference Predicate Device. | | Mode of Action / Operating Principle | The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces alone. | The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. | The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces alone. | Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a doctor's prescription. | Equivalent The mode of operation of the Subject Device is largely equivalent to that of the Primary Predicate Device and is identical to that of the K210320 Reference Predicate Device. | | Feature | Subject Device ClearCorrect System | Primary Predicate Device Invisalign System (K143630) | Reference Device ClearCorrect System (K210320) | Reference Device Spark Clear Aligner Sys. (K203737) | Equivalence Discussion | | Aligner Material | Thermoplastic polyurethane-polyester composite resin, tradename ClearQuartz | Thermoplastic polymer | Thermoplastic polyurethane-polyester composite resin, tradename ClearQuartz | Thermoplastic polyurethane-polyester composite resin, tradename TruGEN | Identical The Subject Aligner material is identical to that of the Reference Devices per K210320 and K203737. | | Sterilization | Provided in non-sterile condition. Not intended to be sterilized before use. | Provided in non-sterile condition. Not intended to be sterilized before use. | Provided in non-sterile condition. Not intended to be sterilized before use. | Provided in non-sterile condition. Not intended to be sterilized before use. | Identical The status of the Subject devices is identical to that of the Reference Device per K210320. | | Singe Use/ Reuse | Repeated use by a single patient | Repeated use by a single patient | Repeated use by a single patient | Repeated use by a single patient | Identical The use profile of the Subject devices is identical to that of the Reference Device per K210320. | | Packaging | Primary: LDPE bag containing one or two appliances as defined by the prescribed treatment plan. Secondary: 20 pt C1S SBS paperboard box | Unknown | Primary: LDPE bag containing one or two appliances as defined by the prescribed treatment plan. Secondary: 20 pt C1S SBS paperboard box | Unknown | Identical The packaging for the Subject devices is identical to that of the Reference Device per K210320. | | Feature | Subject Device ClearCorrect System | Primary Predicate Device Invisalign System (K143630) | Reference Device ClearCorrect System (K210320) | Reference Device Spark Clear Aligner Sys. (K203737) | Equivalence Discussion | | Treatment Planning Software Description | ClearCorrect technicians using the ClearCorrect Cut and Stage software use a scan of a PVS impression or the output of an intra-oral scanner of the patient's untreated oral anatomy and the prescription details to derive the desired final patient tooth positions. Using this desired state, the software interprets a series of intermediate states that adhere to defined maximum tooth motions and clinician instructions. The technician further refines these intermediate states manually as necessary to facilitate the desired outcome. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners | The Align 3-D Software uses a scan of a PVS impression or a digital scan (which represents an untreated state) to generate the image of a final, treated state and then interprets a series of images that represent intermediate teeth states. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners | ClearCorrect technicians using the ClearCorrect Cut and Stage software use a scan of a PVS impression or the output of an intra-oral scanner of the patient's untreated oral anatomy and the prescription details to derive the desired final patient tooth positions. Using this desired state, the software interprets a series of intermediate states that adhere to defined maximum tooth motions and clinician instructions. The technician further refines these intermediate states manually as necessary to facilitate the desired outcome. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners | The Spark™ Clear Aligner System 3-D software uses scanned teeth data, landmarks and the clinician's prescription to design a corrected case setup for the clinician's review. The output files from this software are sent to the clinician, who may suggest improvements or approve as-is for manufacture. The software is used to produce pre- molds and molds needed for the manufacturing of series of custom-made aligners. | Identical The software used by technicians internal to ClearCorrect is identical to that used with the Reference Predicate Device. The software is functionally equivalent to the software of the Primary Predicate. | | Feature | Subject Device ClearCorrect System | Primary Predicate Device Invisalign System (K143630) | Reference Device ClearCorrect System (K210320) | Reference Device Spark Clear Aligner Sys. (K203737) | Equivalence Discussion | | Clinician Interface Software Description | The ClearCorrect Doctor Portal is used by the clinician to initiate new treatment cases coordinating the provision of dental records, the prescription, and any other treatment instructions. Doctor Portal also allows the clinician to manage existing cases and address any actions associated with those cases. The ClearCorrect ClearPilot™ allows the clinician to view, comment and approve the orthodontic treatment plan. ClearPilot also allows the clinician to monitor treatment progress against the plan and to share the plan with the patient. | ClinCheck Software is an electronic prescription form and process used to depict, edit, view, monitor and approve an orthodontic treatment plan. Treatment Plan File: The plan downloads to other computing devices (e.g., tablets) The plan is deleted upon exiting application | The ClearCorrect Doctor Portal is used by the clinician to initiate new treatment cases coordinating the provision of dental records, the prescription, and any other treatment instructions. Doctor Portal also allows the clinician to manage existing cases and address any actions associated with those cases. The ClearCorrect ClearPilot allows the clinician to view, comment and approve the orthodontic treatment plan. ClearPilot also allows the clinician to monitor treatment progress against the plan and to share the plan with the patient. | Unknown | Equivalent The combination of Subject device clinician interface software provides the same functionality as the Primary Predicate Device ClinCheck software and is identical to that of the Reference Device. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------

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