Pearl Clear Aligner

{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 16th, 2025 Pearl Digital Inc. % Patsv Trisler Regulatory Consultant Pear Digital Inc. 2975 Scott Blvd., Ste 110 Santa Clara, California 95054 Re: K242715 Trade/Device Name: Pearl Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 12, 2024 Received: December 12, 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. {1}------------------------------------------------ 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 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-regulatory {2}------------------------------------------------ assistance/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 OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K242715 Device Name Pearl Clear Aligner Indications for Use (Describe) The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces. 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." {4}------------------------------------------------ Submitter: Pearl Digital, Inc. Pearl Clear Aligner K242715 Traditional Premarket Notification 510(k) SUBMITTER Name: Pearl Digital, Inc. 2975 Scott Blvd STE 110 Address: Santa Clara, CA 95054 Contact Person: | Henry H. Cao, CEO | Contact Person: | Henry H. Cao, CEO | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Email: | henrycao@pearl-digital.com | | Date Prepared: | December 12, 2024 | | DEVICE Trade Name: | Pearl Clear 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 | | PRIMARY PREDICATE: | K211510, uLab Systems Dental Aligner Kit, uLab Systems, Inc. | | REFERENCE DEVICE: | K201036, PlaniMax Orthodontic Software, Choice Biotech Inc. | | DEVICE DESCRIPTION | Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic 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 a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function. | | MECHANISM OF ACTION | Each aligner in the set is used for the specified period of time, usually 1-2 weeks, to exert gentle forces to achieve progressive realignment of the teeth until the planned correction has been achieved. The daily treatment time is approximately 22 hours, or except during eating, based on the clinician's prescribed treatment plan. The aligner trays are held in place by pressure and can be removed by the patients at any time. | | SUMMARY OF<br>TECHNOLOGICAL<br>CHARACTERISTICS | The thermoplastic polyurethane material used for the<br>manufacture of the Pearl Clear Aligner is similar to the material<br>used to make the predicate aligners.<br><br>The treatment planning software system used is Choice<br>Biotech, Inc's. PlaniMax Orthodontic Software, K201036<br>(Reference device). | | INDICATIONS FOR<br>USE STATEMENT | The Pearl Clear Aligner is indicated for the alignment of teeth<br>during orthodontic treatment of malocclusions by continuous<br>gentle forces. | | SAFETY TESTING | Testing according to ISO 10993, Biological evaluation of<br>medical devices – Part 1: Evaluation and testing within a risk<br>management system, was performed by a GLP-certified<br>contract research laboratory:<br>In vitro Cytotoxicity (Part 5) Oral Mucosal Irritation (Part 10) Skin Sensitization (Part 10) Acute Systemic Toxicity (Part 11) Implantation (Part 6) Subacute Systemic Toxicity (Part 11) Subchronic Toxicity (Part 11) Pyrogen Testing was performed according to USP 45/NF40<br><151>. | | OTHER TESTING | Bench testing was performed to validate the manufacturing<br>process to ensure the accuracy of the final aligners compared<br>to the initial digital scans. A final report was part of the 510(k)<br>package.<br><br>In vivo Animal and Human Clinical performance testing are not<br>required for this device category. | | COMPARISON TO<br>THE PREDICATE<br>DEVICE | The Pearl Digital Aligners device has the same intended use as<br>the predicate device. The thermoplastic polymer material is<br>similar and the aligners are designed by commercially available<br>treatment planning software (Reference Device). The<br>processes for fabrication of the clear aligners, while proprietary<br>to each manufacturer, make use of similar, industry-standard<br>processes using similar machines and materials.<br><br>Any differences in the materials, treatment planning software<br>and specific manufacturing processes do not raise new<br>questions of safety and effectiveness. | | SUBSTANTIAL<br>EQUIVALENCE<br>CONCLUSION | The information and data provided in this 510(k) establish that<br>the Pearl Digital Aligners device is substantially equivalent to<br>the predicate device in the intended use, design, principle of<br>operation, technology, including use of similar thermoplastic<br>polymer materials used to make the aligners. See the following<br>SE Comparison table. | {5}------------------------------------------------ {6}------------------------------------------------ Submitter: Pearl Digital, Inc. | 510(k) Number | Proposed Device<br>K242715 | Predicate #1<br>K211510 | SE Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Device Name | Pearl Clear Aligner | uLab Systems Dental Aligner<br>Kit | N/A | | Manufacturer | Pearl Digital, Inc. | uLab Systems, Inc. | N/A | | Classification<br>Regulation | 21 CFR 872.5470 | 21 CFR 872.5470 | Same | | Name<br>Product Code<br>Class | Orthodontic Plastic Bracket<br>NXC<br>2 | Orthodontic Plastic Bracket<br>NXC<br>2 | | | Indications for<br>Use | The Pearl Clear Aligner is<br>indicated for the alignment of<br>teeth during orthodontic<br>treatment of malocclusions by<br>continuous gentle forces. | The uLab Systems Dental<br>Aligner is indicated for the<br>alignment of teeth during<br>orthodontic treatment of<br>malocclusions by way of<br>continuous gentle forces. | Substantially<br>equivalent<br>intended use and<br>Indications for<br>Use statement | | Mode of Action | The removable appliance<br>applies continuous gentle<br>forces on teeth according to<br>the plan prescribed by the<br>doctor. | The removable appliance<br>applies continuous gentle<br>forces on teeth according to<br>the plan prescribed by the<br>doctor. | Both apply<br>continuous gentle<br>forces to achieve<br>teeth realignment | | Description of<br>Use | Each removable preformed<br>plastic tray, prescribed by the<br>Dr, is worn by the patient<br>usually for 1-2 weeks, prior to<br>using the next sequential<br>aligner tray according to Dr's<br>direction. | Each removable preformed<br>plastic tray, prescribed by the<br>Dr, is worn by the patient<br>usually for 1-2 weeks, prior to<br>using the next sequential<br>aligner tray according to Dr's<br>direction. | Wear time per<br>day and per<br>sequential set is<br>similar. | | Material | Thermoplastic polyurethane | Thermoplastic polyurethane | Both are<br>thermoplastic<br>sheets | | Manufacturing<br>Process | Forming of plastic sheets on<br>SD printed dental models<br>designed with use of the<br>treatment planning software | Forming of plastic sheets on<br>SD printed dental models<br>designed with use of the<br>treatment planning software | Processes are<br>different<br>(proprietary) but<br>similar and<br>according to<br>industry<br>standards. | | Software | Commercially available<br>treatment planning software is<br>used. | Commercially available<br>treatment planning software is<br>used. | Software is<br>different but both<br>are commercially<br>available for<br>orthodontic<br>treatment<br>planning. | | Prescription Use | Rx | Rx | Both require<br>prescription. | | Biocompatibility | Testing to meet requirements<br>for Category C | Testing to meet requirements<br>for Category C | Standard ISO<br>10993 testing<br>conducted on the<br>thermoplastic<br>materials. | | Process<br>Validation<br>Testing | Performed | Performed | Similar testing<br>performed. | ## Substantial Equivalence Comparison Table {7}------------------------------------------------ Submitter: Pearl Digital, Inc.