(61 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on 3D printing and physical properties, with no mention of automated decision-making or data processing beyond what's conventionally involved in CAD/CAM for orthodontic aligners.
Yes
The device is indicated for the treatment of tooth malocclusion, which is a medical condition, and it repositions teeth by applying continuous gentle force, thus providing a therapeutic effect.
No
Explanation: The device is an aligner system used for the treatment of tooth malocclusion by repositioning teeth. It does not provide any diagnostic information or assessment.
No
The device is a physical product (clear aligners) made from biocompatible resins and 3D printed. While "software usage" is mentioned in comparison to predicate devices, the core of the device is the physical aligner, not software. The performance studies focus on mechanical, chemical, and biological properties, not software validation.
No.
The device is a physical orthodontic system used to reposition teeth, not a diagnostic tool for performing tests on samples derived from the human body.
N/A
Intended Use / Indications for Use
The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
Dental health professionals achieve orthodontic tooth movement through prescription of aligners which apply force to the patient's teeth so that each tooth follows a prescribed, predetermined displacement. LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state.
A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability.
The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with twelve-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.
The LuxCreo Clear Aligner System mechanism of operation, and software usage, are identical to the predicate devices, and support a determination of substantial equality. Both the LuxCreo Clear Aligner System and the predicate devices are manufactured from a biocompatible, non-sterile polyurethane materials that supports a determination of substantial equality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
Prescribing dental health professional
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)
The following performance data were provided to demonstrate substantial equivalence:
- A. ISO 10993-3:2014 Genotoxicity test
- B. ISO 10993-5 In vitro Cytotoxicity
- C. ISO 10993-6:2016 Subcutaneous Implantation Test
- D. ISO 10993-10 Oral Mucosa Irritation
- E. USP Pyrogen Study
- F. ISO 10993-10 Skin Sensitization (Maximization Test)
- G. ISO 10993-11 Acute Systemic Toxicity
- H. ISO 10993-11:2017 Sub-chronic systemic toxicity
- I. Transportation and accelerating ageing tests were validated and completed.
- J. Physical, chemical and mechanical properties were tested.
- K. Design verification, validation and manufacturing validation were completed. All the results meet the product specification requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Ultimate Flexural Strength: 34.61 ± 0.76 MPa
Flexural Modulus: 1040.02 ± 39.59 MPa
Shore D Hardness: 63 ± 1.0 HD
Stress Relaxation: 41.56±0.0044%; No cracking was found.
Water solubility: 0.39±0.04 µg/mm³
Water absorption: 10.03±1.01 µg/mm³
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - LuxCreo Clear Aligner System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 8, 2025
LuxCreo Inc.
Tao Feng
VP of Legal
350 W. Ontario Street
Suite 700
Chicago, Illinois 60654
Re: K250343
Trade/Device Name: LuxCreo Clear Aligner System
Regulation Number: 21 CFR 872.5470
Regulation Name: Orthodontic Plastic Bracket
Regulatory Class: Class II
Product Code: NXC
Dated: March 10, 2025
Received: March 10, 2025
Dear Tao Feng:
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.
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250343 - Tao Feng Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250343
Device Name
LuxCreo Clear Aligner System
Indications for Use (Describe)
The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.
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."
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(650) 336-0888
350 W. Ontario Street, Suite 700
Chicago, IL 60654, USA
www.luxcreo.com
info@luxcreo.com
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Section 20-3 Special 510 (k) Summary
A. 510(k) Number
B. Date Prepared
January 26, 2025
C. Submitter
LuxCreo Inc.
350 W. Ontario Street Suite 700, Chicago, IL 60654
Registration Number: 3016237718
FEI Number: 3016237718
Tel:+1 650-336-0888
D. Contact Person
Tao Feng
Title: VP of Legal
Telephone Number: 732-301-4246
Email: tao.feng@luxcreo.com
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E. Device
- Device Name: LuxCreo Clear Aligner System
- Device Classification Name: Sequential Aligner
- Regulation Description: Orthodontic Plastic Bracket
- Regulation Number: 21 CFR 872.5470
- Device Class: Class II
- Product Code: NXC
- Review Panel: Dental
F. Indication(s) for Use
LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.
G. Predicate Device
- Device Name: LuxCreo Clear Aligner System
- 510(k) number: K212680
- Common Name: Sequential Aligner
- Regulation Name: Orthodontic Plastic Bracket
- Regulation Number: 21 CFR 872.5470
- Device Class: Class II
- Product Code: NXC
- Review Panel: Dental
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Chicago, IL 60654, USA
www.luxcreo.com
info@luxcreo.com
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H. Device Description
Dental health professionals achieve orthodontic tooth movement through prescription of aligners which apply force to the patient's teeth so that each tooth follows a prescribed, predetermined displacement. LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state.
A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability.
The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with twelve-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.
The LuxCreo Clear Aligner System mechanism of operation, and software usage, are identical to the predicate devices, and support a determination of substantial equality. Both the LuxCreo Clear Aligner System and the predicate devices are manufactured from a biocompatible, non-sterile polyurethane materials that supports a determination of substantial equality.
I. Comparison of Technical Logical Characteristics with the Predicate Device
LuxCreo Clear Aligner System and predicate devices (K212680) have:
- Same intended use/ indication(s) for use
- Same intended population
- Same mode of action
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Chicago, IL 60654, USA
www.luxcreo.com
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- Same method of use
- Same duration of use
- Same required using software for ordering workflow
- Removable devices
- Same manufacturing process
- Same biocompatibility evaluation and testing
- Same technical specifications evaluation and testing
- Different materials
- Different shelf life
Material modification was made to the proposed device. The mechanical and chemical properties of the proposed device, including flexural modulus, flexural strength, shore D harness, stress relaxation, water solubility and water absorption, were assessed using the same test methods and pre-determined acceptance criteria. All the mechanical and chemical properties passed the tests successfully and demonstrates equivalent and/or better performance to the predicate device. The proposed device stability and packaging integrity were assessed using the same test method and pre-determined acceptance criteria. Test results verify the proposed device can be labeled with 12-month shelf life.
As presented in the 510(k) and summarized herein, LuxCreo Inc. concludes that the LuxCreo Clear Aligner System is substantially equivalent to predicate devices in regard to indications for use, design, and technology.
J. Substantial Equivalence Comparison Table – Manufacturing Process
| Items | Proposed Device (K250343) | Predicate Device (K212680) |
|---|---|---|
| Method of Manufacturing | Same | Light-cured 3D printing |
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Chicago, IL 60654, USA
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| Items | Proposed Device (K250343) | Predicate Device (K212680) |
|---|---|---|
| Technical Specifications of 3D Printing | Same | DLP/ SLA 3D printer UV cured 3D printing resin for medical device manufacturing. |
| Manufacturing process workflow | Same | Raw 3D printing material in combination with LuxCreo's manufacturing system. |
K. Substantial Equivalence Comparison Table -Basic Information
| Items | Proposed Device (K250343) | Predicate Device (K212680) |
|---|---|---|
| 510(k) Number | TBD | K212680 |
| Product Code | Same | NXC |
| Device Classification | Same | Class II |
| Intended Use/Indication(s) for Use | Same | The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force. |
| Mode of Action | Same | Alignment of teeth by application of continuous gentle force, by sequential use by the dental practitioner. Orthodontic of preformed plastic trays. |
| Method of Use | Same | Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next sequential |
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Chicago, IL 60654, USA
www.luxcreo.com
info@luxcreo.com
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| Items | Proposed Device (K250343) | Predicate Device (K212680) |
|---|---|---|
| aligner tray. | ||
| OTC/Rx | Same | Rx |
| Duration of Use | Same | 20-22 hours/day |
| Method of Manufacturing | Same | Light-cured 3D printing |
L. Substantial Equivalence Comparison Table – Physical and Mechanical Properties
| Items | Proposed Device (K250343) | Predicate Device (K212680) |
|---|---|---|
| Ultimate Flexural Strength | 34.61 ± 0.76 MPa | 23.6 ± 1.9 MPa |
| Flexural Modulus | 1040.02 ± 39.59 MPa | 804 ± 64 MPa (ISO 20795-2:2013) |
| Shore D Hardness | 63 ± 1.0 HD | 21.63±0.38 HD |
| Stress Relaxation | 41.56±0.0044%; No cracking was found. | 37.3 ± 0.3%; No cracking was found. |
| Water solubility | 0.39±0.04 µg/mm³ | 3.668±1.0748 µg/mm³ |
| Water absorption | 10.03±1.01 µg/mm³ | 19.952±6.6719 µg/mm³ |
| Shelf Life | 12 Months | 6 Months |
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Chicago, IL 60654, USA
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M. Summary of Performance Data
The following performance data were provided to demonstrate substantial equivalence:
- A. ISO 10993-3:2014 Genotoxicity test
- B. ISO 10993-5 In vitro Cytotoxicity
- C. ISO 10993-6:2016 Subcutaneous Implantation Test
- D. ISO 10993-10 Oral Mucosa Irritation
- E. USP Pyrogen Study
- F. ISO 10993-10 Skin Sensitization (Maximization Test)
- G. ISO 10993-11 Acute Systemic Toxicity
- H. ISO 10993-11:2017 Sub-chronic systemic toxicity
- I. Transportation and accelerating ageing tests were validated and completed.
- J. Physical, chemical and mechanical properties were tested.
- K. Design verification, validation and manufacturing validation were completed. All the results meet the product specification requirements.
N. Substantial Equivalence Conclusion
Based upon the information presented in this section, LuxCreo Inc. concludes that the LuxCreo Clear Aligner System is substantially equivalent to predicate device (K212680) in regard to indications for use, design, and technology.
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