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 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the CREOKORREKT Aligners. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with detailed acceptance criteria and performance metrics against a defined ground truth as would be common for novel high-risk devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within this 510(k) summary.

Here's why and what information can be extracted:

510(k) Submissions: These primarily rely on non-clinical testing (e.g., material properties, biocompatibility) and comparison to predicate devices to demonstrate that the new device is as safe and effective as a device already on the market. They typically do not involve the kind of comparative effectiveness studies (e.g., MRMC studies with human readers and AI assistance) or standalone algorithm performance studies with detailed ground truth analysis that would be needed to answer your specific questions.
"Acceptance Criteria" in this context: The "acceptance criteria" mentioned in the document relate to the manufacturing process validation test, which assesses if the manufactured aligner matches the software treatment design and achieves its intended use. This is a different type of acceptance criterion than, for example, a diagnostic device's sensitivity/specificity targets against a clinical ground truth.

Extracted Information (based on the document's content):

Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria (as implied/stated)	Reported Device Performance
Physical Properties Testing	Meets requirements of ASTM D6387, ASTM D790, ASTM D570, and ASTM D5420.	Demonstrated substantial equivalence (implicit passed).
Biocompatibility Testing	Meets requirements of ISO 10993-3, 5, 10, and 11.	Demonstrated substantial equivalence (implicit passed).
Manufacturing Process Validation Testing	"Evaluated the fit, form, and function of the final product by a trained physician as compared to software treatment design."	"Met the pre-established acceptance criteria." "Achieves its intended use, and it is substantially equivalent to the predicate devices."

Sample Size used for the test set and the data provenance:
- The document does not specify the sample size for the manufacturing process validation test or any other "test set" in the context of clinical performance.
- Data provenance for clinical outcomes is not mentioned, as this was not a clinical study to prove effectiveness.
Number of experts used to establish the ground truth for the test set and their qualifications:
- The document mentions evaluation "by a trained physician" for the manufacturing process validation. It does not specify the number of physicians or their detailed qualifications beyond "trained."
- No "ground truth" in a clinical sense (e.g., pathology, outcomes data) was established for an efficacy study. The ground truth for the manufacturing validation was the software treatment design.
Adjudication method for the test set:
- Not applicable as a formal adjudication method for a clinical test set is not described. The document only mentions evaluation by a "trained physician" against the software design.
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:
- No MRMC comparative effectiveness study was done. The device is a physical aligner, not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device. The "algorithm" here refers to the dental design software which guides the manufacturing, not a standalone AI for diagnosis or treatment decision.
The type of ground truth used:
- For the manufacturing process validation, the "ground truth" was the software treatment design. For other non-clinical tests (material properties, biocompatibility), the ground truth generally refers to the standards/specifications that the material must meet.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithm development for clinical performance. The manufacturing process uses software for design, but it's not described as an AI system requiring a training set in the clinical performance sense.
How the ground truth for the training set was established:
- Not applicable, as no training set (in the context of AI/ML) is mentioned or implied for clinical performance evaluation.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K211427

Device Name CREOKORREKT Aligners

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

Device Description:

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scanning or a physical impression (PVS Impression) and sends them with a prescription to CreoDent Prosthetics LTD.

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.
ClassificationNumber	21 CFR 872.5470, Class IIOrthodontic Plastic Bracket	21 CFR 872.5470, Class IIOrthodontic Plastic Bracket	21 CFR 872.5470, Class IIOrthodontic Plastic Bracket
Product Code	NXC	NXC	NXC
Indicationsfor Use	The CREOKORREKT Aligneris indicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e.all second molars). The alignerpositions teeth by way ofcontinuous gentle force.	The Argen Clear Aligner andArgen Clear Aligner Premiumare indicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). The aligner positionsteeth by way of continuousgentle force.	The uLab Systems DentalAligner is indicated for thealignment of permanent teethduring orthodontic treatmentof malocclusions by way ofcontinuous gentle forces.
Modeof action	The appliance applies gentleforces on teeth according to theplan prescribed by the doctor.	The appliance applies gentleforces on teeth according to theplan prescribed by the doctor.	Orthodontic movementoccurs through continuousgentle forces applied to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.
Descriptionof Use	Each removable preformedplastic tray is worn by thepatient as prescribed by thedoctor, usually a few weeksprior to using the next sequentialaligner tray.	Each removable preformedplastic tray is worn by thepatient as prescribed by thedoctor, usually a few weeksprior to using the nextsequential aligner tray.	A series of custom-maderemovable clear plasticorthodontic aligners thatsequentially position teeth byway of continuous gentleforce.
Material	Zendura A (thin thermoformedpolyurethane) or Zendura FLX(copolyester and polyurethanecomposite)	Thermoplastic polyurethanepolyester composite resin	Zendura A (thinthermoformed polyurethane)or Zendura FLX (copolyesterand polyurethane composite)

The subject device is substantially equivalent to the current cleared devices. Comparison demonstrating Substantial Equivalence follows:

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Manufacturingprocesses	- Scanning- Treatment planning- aligner model by 3D printer- pressure molding by heatingmachine- laser engraving	- Scanning- Treatment planning- aligner model by 3D printer- pressure molding by heatingmachine	- Scanning- Treatment planning- aligner model by 3D printer- pressure molding by heatingmachine
Thickness of material	0.76mm	-	-
Color of material	Clear	Clear	Clear
Software usedfor treatmentplanning/manufacture	Ortho System TM; 3Shape A/S(K180941)Autolign; Diorco (K192847)	Ortho System TM; 3Shape A/S(K180941)	uDesign; uLab Systems Inc.(K171295)
Prescription Use	Rx	Rx	Rx
Biocompatibility	Yes, shown to meetrequirements of ISO 10993	Yes, shown to meetrequirements of ISO 10993	Yes, shown to meetrequirements 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.

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.