Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional process of dental design software used by a human designer based on a dentist's prescription. There is no mention of AI or ML being used in the treatment planning or fabrication process.

Therapeutic

Yes.

The device is indicated for the "treatment of tooth malocclusion," which is a therapeutic purpose.

Diagnostic

No

The device description clearly states that the CREOKORREKT Aligner is "indicated for the treatment of tooth malocclusion" and functions by "moving the patient's teeth." It is a therapeutic device designed to correct a condition, not to diagnose one. The diagnostic step (assessment by a dentist) happens before the aligner is prescribed and designed.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device consists of "thermoformed polyurethane and copolyester orthodontic appliances," which are physical hardware components. While software is used in the design process, the final device is a physical aligner.

IVD (In Vitro Diagnostic)

Based on the provided information, the CREOKORREKT Aligner is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Examples include blood tests, urine tests, or tissue biopsies.
The CREOKORREKT Aligner is a physical appliance used to mechanically move teeth. It is a therapeutic device, not a diagnostic one.
The input data (intraoral scans or impressions) are used to create a physical model and plan the mechanical movement of teeth, not to diagnose a disease or condition based on biological markers.

The device description clearly states its purpose is to "position teeth by way of continuous gentle force" and is an "alternative to conventional wire and bracket orthodontic technology and fixed appliances for the treatment of patients with tooth malocclusion." This aligns with the definition of a therapeutic orthodontic device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

NXC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

intraoral scanning or a physical impression (PVS Impression)

Anatomical Site

teeth

Indicated Patient Age Range

patients with permanent dentition (i.e. all second molars)

Intended User / Care Setting

dentist

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192846

Reference Device(s)

K192596

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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

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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)

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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:

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
Number	21 CFR 872.5470, Class II
Orthodontic Plastic Bracket	21 CFR 872.5470, Class II
Orthodontic Plastic Bracket	21 CFR 872.5470, Class II
Orthodontic Plastic Bracket
Product Code	NXC	NXC	NXC
Indications
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.	The Argen Clear Aligner and
Argen Clear Aligner Premium
are 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.	The uLab Systems Dental
Aligner is indicated for the
alignment of permanent teeth
during orthodontic treatment
of malocclusions by way of
continuous gentle forces.
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.	Orthodontic movement
occurs through continuous
gentle forces applied to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription.
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.	A series of custom-made
removable clear plastic
orthodontic aligners that
sequentially position teeth by
way of continuous gentle
force.
Material	Zendura A (thin thermoformed
polyurethane) or Zendura FLX
(copolyester and polyurethane
composite)	Thermoplastic polyurethane
polyester composite resin	Zendura A (thin
thermoformed polyurethane)
or Zendura FLX (copolyester
and polyurethane composite)

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

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| Manufacturing
processes | - Scanning

Treatment planning
aligner model by 3D printer
pressure molding by heating
machine
laser engraving | - Scanning
Treatment planning
aligner model by 3D printer
pressure molding by heating
machine | - Scanning
Treatment planning
aligner model by 3D printer
pressure molding by heating
machine |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Thickness of material | 0.76mm | - | - |
| Color of material | Clear | Clear | Clear |
| Software used
for treatment
planning/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 meet
requirements of ISO 10993 | Yes, shown to meet
requirements of ISO 10993 | Yes, shown to meet
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.