CREOKORREKT Aligners

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. October 13, 2022 CreoDent Prosthetics LTD % April Lee Regulatory Affairs Consultant Withus Group Inc. 106 Superior. Irvine, CA 92620 Re: K211427 Trade/Device Name: CREOKORREKT Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 14, 2021 Received: September 15, 2021 Dear April Lee: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 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, For 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) K211427 Device Name CREOKORREKT Aligners Indications for Use (Describe) The CREOKORREKT Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force. > 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 This summary is being submitted in accordance with requirements of 21 CFR Part 807.92. #### Submitter CreoDent Prosthetics LTD Calvin Shim 545 West 45th Street 11FL New York, NY 10036 USA Email: calvincreo@gmail.com Tel. +82-53-589-3541 Fax. +82-53-289-7922 ## Official Correspondent Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122 #### Device Information - Proprietary Name: CREOKORREKT Aligners - Common Name: Orthodontic Sequential Aligner - Classification Name: Orthodontic plastic bracket - Classification: Class II, 21 CFR 872.5470 ● - Classification Product Code: NXC - Panel: Dental . - . Date Prepared: 10/12/2022 ## Predicate Devices: Primary Predicate K192846, Argen Clear Aligner by Argen Corporation Reference Device K192596, uLab Systems Dental aligner by uLab Systems Inc. ## Indication for Use: The CREOKORREKT Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force. ## Device Description: CREOKORREKT Aligners consist of a series of dentist-prescribed, thin, clear, thermoformed polyurethane and copolyester orthodontic appliances. The aligners provide gentle continuous force to move the patient's teeth in small increments from their original positions to planned positions. CREOKORREKT Aligners are intended as an alternative to conventional wire and bracket orthodontic technology and fixed appliances for the treatment of patients with tooth malocclusion. A dentist determines a treatment plan based on the assessment of the patient's teeth and prescribes the CREOKORREKT. To obtain the dimensions and details of a patient's dentition, a dentist takes intraoral {4}------------------------------------------------ scanning or a physical impression (PVS Impression) and sends them with a prescription to CreoDent Prosthetics LTD. With PVS impressions, physical models are fabricated and scanned. Scanned data are directly imported into dental design software for planning. CreoDent Prosthetics LTD designs the process of treatment by creating a series of the sequential model intended to gradually move the patient's teeth to the desired position in accordance with the dentist's prescription utilizing the dental design software. The doctor reviews and approves the treatment scheme. CreoDent Prosthetics LTD fabricates a series of models for thermoforming. #### Summary of Technology Characteristics | Subject Device | Primary Predicate | Reference Device | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | CREOKORREKT | Argen Clear Aligner | uLab Systems Dental aligner | | 510(k) Number | K211427 | K192846 | K192596 | | Manufacturer | CreoDent Prosthetics LTD | Argen Corporation | uLab Systems Inc. | | Classification<br>Number | 21 CFR 872.5470, Class II<br>Orthodontic Plastic Bracket | 21 CFR 872.5470, Class II<br>Orthodontic Plastic Bracket | 21 CFR 872.5470, Class II<br>Orthodontic Plastic Bracket | | Product Code | NXC | NXC | NXC | | Indications<br>for Use | The CREOKORREKT Aligner<br>is indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition (i.e.<br>all second molars). The aligner<br>positions teeth by way of<br>continuous gentle force. | The Argen Clear Aligner and<br>Argen Clear Aligner Premium<br>are indicated for the treatment<br>of tooth malocclusion in<br>patients with permanent<br>dentition (i.e. all second<br>molars). The aligner positions<br>teeth by way of continuous<br>gentle force. | The uLab Systems Dental<br>Aligner is indicated for the<br>alignment of permanent teeth<br>during orthodontic treatment<br>of malocclusions by way of<br>continuous gentle forces. | | Mode<br>of action | The appliance applies gentle<br>forces on teeth according to the<br>plan prescribed by the doctor. | The appliance applies gentle<br>forces on teeth according to the<br>plan prescribed by the doctor. | Orthodontic movement<br>occurs through continuous<br>gentle forces applied to the<br>dentition as each tooth<br>follows the programmed<br>displacement based on a<br>doctor's prescription. | | Description<br>of Use | Each removable preformed<br>plastic tray is worn by the<br>patient as prescribed by the<br>doctor, usually a few weeks<br>prior to using the next sequential<br>aligner tray. | Each removable preformed<br>plastic tray is worn by the<br>patient as prescribed by the<br>doctor, usually a few weeks<br>prior to using the next<br>sequential aligner tray. | A series of custom-made<br>removable clear plastic<br>orthodontic aligners that<br>sequentially position teeth by<br>way of continuous gentle<br>force. | | Material | Zendura A (thin thermoformed<br>polyurethane) or Zendura FLX<br>(copolyester and polyurethane<br>composite) | Thermoplastic polyurethane<br>polyester composite resin | Zendura A (thin<br>thermoformed polyurethane)<br>or Zendura FLX (copolyester<br>and polyurethane composite) | The subject device is substantially equivalent to the current cleared devices. Comparison demonstrating Substantial Equivalence follows: {5}------------------------------------------------ | Manufacturing<br>processes | - Scanning<br>- Treatment planning<br>- aligner model by 3D printer<br>- pressure molding by heating<br>machine<br>- laser engraving | - Scanning<br>- Treatment planning<br>- aligner model by 3D printer<br>- pressure molding by heating<br>machine | - Scanning<br>- Treatment planning<br>- aligner model by 3D printer<br>- pressure molding by heating<br>machine | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Thickness of material | 0.76mm | - | - | | Color of material | Clear | Clear | Clear | | Software used<br>for treatment<br>planning/manufacture | Ortho System TM; 3Shape A/S<br>(K180941)<br>Autolign; Diorco (K192847) | Ortho System TM; 3Shape A/S<br>(K180941) | uDesign; uLab Systems Inc.<br>(K171295) | | Prescription Use | Rx | Rx | Rx | | Biocompatibility | Yes, shown to meet<br>requirements of ISO 10993 | Yes, shown to meet<br>requirements of ISO 10993 | Yes, shown to meet<br>requirements of ISO 10993 | ## SE Discussion The subject device and primary predicate, K192846 have same indications for Use, mode of action, description of use, thermoformed copolyester and polyurethane composite material (Zendura FLX), manufacturing process (i.e., Scanning, Treatment planning, Thermoforming, etc.), thickness of material, color of material, and treatment planning software. The differences between the subject device and primary predicate are the material (Zendura A) and using software (Autolign: Diorco). To support the discrepancy of the different material, K192596 was added as the reference device for the substantial equivalence. Zendura FLX and Zendura A have been produced in only one film format for each. The film is 0.76mm in thickness. Bay Materials, LLC supplies sheets in different widths and lengths or diameters but all of these are cut from the same film. Therefore, the material of the subject device is identical to that of the predicate devices. To support the discrepancy of the different software used, a manufacturing process validation test was performed and it showed that no significant differences were found between the designs using Autolign (Diorco, K192847) and Ortho Analyzer (3shape, K180941) #### Non-Clinical Testing Non-clinical testing data are submitted to demonstrate substantial equivalence. - Physical properties testing of the material (Zendura A) according to ASTM D6387, ASTM D790, ASTM D570 and ASTM D5420 - Biocompatibility Testing of the material (Zendura FLX and Zendura A) according to ISO 10993-3,5,10, and 11 #### Manufacturing Process Validation Testing This test was conducted to validate the manufacturing process of the final product. It evaluated the fit, form, and function of the final product by a trained physician as compared to software treatment design. This test has met the pre-established acceptance criteria. The test results showed that the manufacturing process of the subject aligner achieves its intended use, and it is substantially equivalent to the predicate devices. #### Conclusion In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, CreoDent Prosthetics LTD concludes that the CREOKORREKT aligner is substantially equivalent to the predicate devices as herein.