(280 days)
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.
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 six-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.
This document is a 510(k) premarket notification for the LuxCreo Clear Aligner System and describes its substantial equivalence to predicate and reference devices. It details the device's indications for use, technological characteristics, and performance data from various tests. However, the document does not contain an acceptance criteria table with reported device performance in the context of device accuracy or clinical performance. Instead, it focuses on demonstrating substantial equivalence through comparisons of:
- Biocompatibility: The document lists several ISO 10993 tests performed (genotoxicity, cytotoxicity, subcutaneous implantation, oral mucosa irritation, pyrogenicity, skin irritation, skin sensitization, acute systemic toxicity, and sub-chronic systemic toxicity). It generally states that these tests indicated the light-cured polyurethane resin is safe to use and that the biocompatibility risks were considered.
- Physical and Mechanical Properties: The document provides values for flexural strength, flexural modulus, Shore D hardness, stress relaxation, water solubility, and water sorption for the proposed device and compares them to reference devices. The comparison often notes "Different" or "Similar" but does not explicitly state acceptance criteria or whether the new device met specific thresholds for these properties.
- Manufacturing Process and Materials: The document highlights the light-cured 3D printing process and light-cured polyurethane resin used for the LuxCreo system, comparing it to the thermoforming process and different materials of predicate devices. It states that "The difference in manufacturing process and base materials did not raise other safety and efficacy concerns" and that these differences "have been tested and validated."
- Design Verification, Validation, and Manufacturing Validation: The document broadly states that these were "completed" and "All the results meet the product specification requirements." However, specific acceptance criteria and detailed results are not provided in this summary.
- Transportation and Accelerated Aging Tests: These were validated and completed.
Based on the provided text, the following information can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria for device performance (e.g., accuracy, clinical efficacy metrics for orthodontic treatment) alongside the reported performance. Instead, it presents various test results for material properties and general statements regarding biocompatibility and manufacturing validation. The comparisons made are primarily to predicate and reference devices to establish "substantial equivalence," not to pre-defined performance acceptance criteria stated within this summary.
Here's a compilation of the reported physical and mechanical properties:
| Items | Proposed Device LuxCreo Clear Aligner System | Acceptance Criteria / Comparison to Predicate/Reference |
|---|---|---|
| Biocompatibility | ISO 10993-3:2014 Genotoxicity test, ISO 10993-5 In vitro Cytotoxicity, ISO 10993-6:2016 Subcutaneous Implantation Test, ISO 10993-10 Oral Mucosa Irritation, USP Pyrogen Study, ISO 10993-10 Skin Irritation, ISO 10993-10 Skin Sensitization (Maximization Test), ISO 10993-11 Acute Systemic Toxicity, ISO 10993-11:2017 Sub-chronic systemic toxicity | "Biocompatibility risks have been considered. The biocompatibility tests indicated that the light-cured polyurethane resin is safe to use." Compared to predicate and reference devices, "Similar" or "Equivalent". |
| Ultimate Flexural Strength | 23.6 ± 1.9 MPa (ISO 20795-2:2013) (Also listed as 40.02±0.08 MPa (ASTM D790) under "Flexural Strength") | Clearly "Different" from the predicate (36.8±1.1 MPa) and reference (2.6—4.4 MPa for KeyPrint KeySplint Soft) devices. |
| Flexural Modulus | 1106.47±13.23 MPa (ASTM D790) 804 ± 64 MPa (ISO 20795-2:2013) | Clearly "Different" from the predicate (1122±24 MPa) and reference (1100-1400 MPa ASTM D790; 135-200 MPa ISO 20795-2) devices for different standards. |
| Shore D Hardness | 21.63±0.38 HD | "Similar" to secondary predicate (21.33±0.06 HD). "Different" from reference devices (80-85 MPa, ≥ 60). |
| Stress Relaxation | 37.3 ± 0.3% No cracking was found. | "Different" from secondary predicate (25.5 ± 0.4%). "No cracking was found" indicates a positive outcome here. |
| Water Solubility | 3.668±1.0748 µg/mm³ | "Different" from reference devices (4.8 µg/mm³; 1.5 - 3.6 µg/mm³). |
| Water Sorption | 19.952±6.6719 µg/mm³ | "Similar" to reference devices (18 µg/mm³; 17.1 - 20.3 µg/mm³). |
| Other Performance Data | Transportation and accelerating aging tests validated and completed. Physical, chemical and mechanical properties tested. Design verification, validation and manufacturing validation completed. | "All the results meet the product specification requirements." (No specific acceptance criteria detailed in this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the tests conducted (biocompatibility, physical/mechanical properties, transportation, aging, design/manufacturing validation). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies described are primarily material and device characterization tests, not clinical evaluations requiring expert interpretation of patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The document describes laboratory testing and validation, not studies requiring expert adjudication for a test set.
5. 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
This information is not applicable and not provided. The LuxCreo Clear Aligner System is a physical medical device (clear aligners) and not an AI-assisted diagnostic tool or software designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. As mentioned above, this device is a physical clear aligner system, not an algorithm, and the application is not an AI-driven standalone system. While it states software is used for ordering workflow, the performance data provided relates to the physical characteristics and safety of the aligners themselves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms or clinical outcomes data is not directly relevant to the performance data presented here. The "ground truth" for the material and physical property tests would be established by the standardized methods and measurements specified (e.g., ASTM D790, ISO 20795-2, ISO 10993 series for biocompatibility). The "truth" for these tests are the measured values themselves as determined by the specific testing protocols.
8. The sample size for the training set
This information is not applicable and not provided. The document describes a physical medical device and its material properties, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
Luxcreo Inc % Ming-Yie Jan Principle Consultant RusCert Technology Co., Ltd 8F., No. 187, Lequn 2nd Rd. Zhongshan Dist. Taipei City, 10462 Taiwan
Re: K212680
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: February 24, 2022 Received: March 2, 2022
Dear Ming-Yie Jan:
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
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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 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) K212680
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 201 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 201.66) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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SECTION 5-510(k) SUMMARY
This 510 (K) summary is being submitted in accorndance with requirements of Title 21,CFR Section 807.92.
- K212680 A. 510(k) NUMBER
| B. | DATE PREPARED May 24th, 2022 |
|---|---|
| C. | SUBMITTER LUXCREO INC.940 Old County Road, Belmont, CA 94002Registration Number: 3016237718FEI Number: 3016237718Tel:+1 650-3360227 |
| D. | CONTACT PERSON Primary Contact PersonC.O.O.Mike Yang+1 650-336-0888Mike.yang@luxcreo.comSecond ContactProject ManagerJethro Wu0970532485Jethro.Wu@LuxCreo.com |
| E. | DEVICE Proprietary Name: LuxCreo Clear Aligner SystemCommon Name: Aligner, SequentialProduct Code: NXCRegulation Number: 21 CFR 872.5470Regulation Name: Orthodontic Plastic BracketDevice Class: Class IIReview 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). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force |
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| G. | PRIMARYPREDICATE DEVICE | Proprietary Name:Common Name:Product Code:Regulation Number:Regulation Name:510(k) Number:510(k) Submitter:Device Class:Review Panel: | ULab Systems Dental Aligner KitSequential AlignerNXC21 CFR 872.5470Orthodontic Plastic BracketK192596uLab Systems, Inc.Class IIDental |
|---|---|---|---|
| H. | SECONDARYPREDICATE DEVICE | Proprietary Name:Common Name:Product Code:Regulation Number:Regulation Name:510(k) Number:510(k) Submitter:Device Class:Review Panel: | ClearCorrect SystemSequential AlignerNXC21 CFR 872.5470Orthodontic Plastic BracketK113618ClearCorrect LLCClass IIDental |
| I. | PRIMARYREFERNCE DEVICE | Proprietary Name:Common Name:Regulation Number:ClassificationProduct Code:Subsequent ProductCode:510(k) Number:510(k) Submitter:Device Class:Review Panel: | KeyPrint KeySplint SoftMouthguard, Prescription/ Positioner,Tooth, PreformedNo associated regulation/ 21 CFR872.5525MQCKMYK183598Keystone IndustriesUnclassified, Class IDental |
| J. | SECONDARYREFERENCEDEVICE | Proprietary Name:Common Name:Regulation Number: | LuxaPrint Ortho PlusPrescription Mouthguard/ Resin, Denture,Relining, Repairing, RebasingNo associated regulation/ 21 CFR872.3760 |
SECTION 5-510(k) SUMMARY Page 2 of 14 pages
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| Classification | MQC |
|---|---|
| Product Code: | |
| Subsequent Product | EBI |
| Code: | |
| 510(k) Number: | K210940 |
| 510(k) Submitter: | DMG Digital Enterprises SE |
| Device Class: | Unclassified, Class II |
| Review Panel: | Dental |
K. DEVICE Dental health professionals achieve orthodontic tooth movement DECRIPTION 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 six-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.
- L. COMPARISON OF TECHNOLOGICAL
LuxCreo Clear Aligner System and predicate devices (K192596 and K113618) are:
SECTION 5-510(k) SUMMARY Page 3 of 14 pages
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CHARACTERISTICS WITH THE PREDICATE DEVICES
- Same intended use/ indication(s) for use 1.
- Same intended population 2.
- Same mode of action 3.
- Same method of use 4.
- న్. Same duration of use
- Required using software for ordering workflow 6.
-
- Removable devices
-
- Different manufacturing process
-
- Different materials
LuxCreo Clear Aligner System and reference devices (K183598 and K210940) are:
- Same light-cured 3 D printing 1.
- Similiar DLP/ SLA 3D printer UV cured 3D printing resin 2. for medical device manufacturing
-
- Similar biocompatibility evaluation and testing.
- Having software involved during the manufacturing 4. ordering and manufacturing process.
The manufacturing process of LuxCreo Clear Aligner System is a light-cured, 3D printing process with light-cured polyurethane resin which is different from the thermoforming process of predicate devices. The biocompatibility risks have been considered. The biocompatibility tests indicated that the lightcured polyurethane resin is safe to use. The light-cured 3D printing process has also been used in the manufacturing of devices in dentistry. The difference in manufacturing process and base materials did not raise other safety and efficacy concerns.
LuxCreo Clear Aligner System and predicate devices (K192596 and K113618) are all the same intended use/ indication(s) for use, intended population, mode of action, method of use, removable devices which requires using a software for ordering workflow. The difference in manufacturing process and materials have been tested and validated. LuxCreo Clear Aligner System performed biocompatibility testing, physical and chemical properties testing of light-cured polyurethane resin.
Both KeyPrint KeySplint Soft, K183598, and LuxaPrint Ortho Plus, K210940, are using DLP/ SLA 3D printer with UV cured 3D printing resin for the intended use of orthodontic and dental appliances such as mouthguards, nightguards, splints and
SECTION 5-510(k) SUMMARY Page 4 of 14 pages
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repositioners. The similar additive manufacturing and based materials between the LuxCreo Clear Aligner System and reference devices are substantially equivalent without extra concerns on their difference of properties.
As presented in the 510(k) and summarized herein, LUXCREO INC. concluded that LuxCreo Clear Aligner System is substantially equivalent to the predicate devices ULab Systems Dental Aligner Kit and the ClearCorrect System (K192596 and K113618) along with the reference devices KeyPrint KeySplint Soft (K183598) and LuxaPrint Ortho Plus (K210940).
SECTION 5-510(k) SUMMARY Page 5 of 14 pages
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(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com
M. A COMPARISON TABLE WITH PREDICATE DEVICES
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Predicate DeviceULab Systems Dental Aligner Kit | Secondary Predicate DeviceClearCorrect System | SubstantialEquivalenceComparisonAssessment |
|---|---|---|---|---|
| 510(k) NumberProduct CodeDeviceClassification | TBDNXCClass II | K192596NXCClass II | K113618NXCClass II | N/ASameSame |
| Intended Use/Indication(s) forUse | LuxCreo Clear Aligner Systemis indicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e.all second molars). TheLuxCreo Clear Aligner Systemrepositions teeth by way ofcontinuous gentle force. | The uLab Systems Dental Aligner isindicated for the alignment ofpermanent teeth during orthodontictreatment of malocclusions by way ofcontinuous gentle forces. | The ClearCorrect System isindicated for the treatment oftooth malocclusion in patientswith permanent.dentition (i.e.all second molars). TheClearCorrect System positionsteeth by way ofcontinuous gentle force. | Same |
| Mode ofAction | Alignment of teeth byapplication of continuousgentle force, by sequential useof preformed plastic trays | Each preformed plastic tray is worn insequence by the patient as prescribedby the dental practitioner. Orthodonticmovement occurs throughcontinuous gentle forces applied to thedentition as each tooth follows theprogrammed displacement based on adoctor's prescription. | Alignment of teeth byapplication of continuousgentleforce, by sequential use ofpreformed plastic trays | Same |
| Method ofUse | Each preformed plastic tray isworn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using the next | During the orthodontic treatment, eachpreformed plastic aligner is worn insequence by the patient as prescribedby the dental practitioner,moving the patient's teeth gradually to | Each preformed plastic tray isworn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using the next | Same |
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Predicate DeviceULab Systems Dental Aligner Kit | Secondary Predicate DeviceClearCorrect System | SubstantialEquivalenceComparisonAssessment |
| sequential aligner tray | the ideal position. | sequential aligner tray | ||
| OTC/Rx | Rx | Rx | Rx | Same |
| Duration of Use | 20-22 hours/day | Each set of aligners can be worn forapproximately 2 weeks of 20-22 hoursof wear per day or according to doctor'sprescription. | 20-22 hours/day | Same |
| Method ofManufacturing | Light-cured 3 D printing | Thermoforming | Thermoforming | Different |
| Software Usedfor OrderingWorkflow | Yes | Yes | Yes | Same |
| Application | Removable | Removable | Removable | Same |
| Biocompatibility | ISO 10993-5 In vitroCytotoxicityISO 10993-10 Oral MucosaIrritationPyrogenISO 10993-10 Skin Irritation inRabbitsISO 10993-10 SkinSensitization in Guinea Pigs(Maximization Test)ISO 10993-11 Acute SystemicToxicity | Raw materials:Cytotoxicity Elution -MEMIntracutaneous/Intradermal ReactivityMaximization for Delayed-TypeHypersensitivityOral Mucosa Irritation TestFinal product:Cytotoxicity Elution -MEM | ISO 10993-5 CytotoxicityISO 10993-10 Intracutaneousreactivity, oral mucosairritation test, maximizationtest for delayed typehypersensitivity | Similar |
| Material | Light-cured polyurethane resin | Zendura A (thin thermoformedpolyurethane) or Zendura FLX(copolyester and polyurethanecomposite) | Thermoplastic polyurethaneresin | Different |
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Predicate DeviceULab Systems Dental Aligner Kit | Secondary Predicate DeviceClearCorrect System | SubstantialEquivalenceComparisonAssessment |
| Design | Image: LuxCreo Clear Aligner System labeled G2 | Image: ULab Systems Dental Aligner Kit | Image: ClearCorrect System | Similardesign |
SECTION 5-510(k) SUMMARY
Page 6 of 14 pages
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(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com
SECTION 5-510(k) SUMMARY
Page 7 of 14 pages
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LUX Creo
(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com
Substantial Equivalence Comparison Table-Predicate Devices-- Mechanical Properties N.
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Predicate DeviceULab Systems Dental Aligner KitK192596 | Secondary Predicate DeviceClearCorrect SystemK113618 | SubstantialEquivalenceComparisonAssessment |
|---|---|---|---|---|
| UltimateFlexuralStrength | 23.6 ± 1.9 MPa | N/A | 36.8±1.1 MPa (ISO 20795-2:2013) | Different |
| FlexuralModulus | 1106.47±13.23 MPa (ASTMD790)804 ± 64 MPa (ISO 20795-2:2013) | N/A | 1122±24 MPa (ISO 20795-2:2013) | Different |
| Shore DHardness | 21.63±0.38 HD | N/A | 21.33±0.06 HD | Similar |
| StressRelaxation | 37.3 ± 0.3%No cracking was found. | N/A | 25.5 ± 0.4%No cracking was found. | Different |
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Reference DeviceKeyPrint KeySplint Soft | Secondary Reference DeviceLuxaPrint Ortho Plus | SubstantialEquivalenceComparisonAssessment |
| 510(k) Number | TBD | K183598 | K210940 | N/A |
| Product Code | NXC | MQC/ KMY | MQC/ EBI | Different |
| DeviceClassification | Class II | Unclassified/ Class II | Unclassified/ Class II | Different |
| Intended Use/Indication(s) forUse | LuxCreo Clear Aligner Systemis indicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e.all second molars). TheLuxCreo Clear Aligner Systemrepositions teeth by way ofcontinuous gentle force. | The KeyPrint® KeySplint Soft™ device isindicated for the fabrication oforthodontic and dental appliances suchas mouthguards, nightguards, splintsand repositioners. | For the fabrication oforthodontic and dentalappliances such asmouthguards, nightguards,splints and positioners. Theproduct is for use withDLP/SLA printers that work atwavelengths of 385 nm or 405nm. | Different |
| Mode ofAction | Alignment of teeth byapplication of continuousgentle force, by sequential useof preformed plastic trays | It depends on the indications of finaldevice. | The device consists of rawmaterial that is used tofabricate removable customdental appliances, such asorthodontic splints and/ormouthguards. The finisheddevices can be used tosupport tooth stabilizationfollowing activeorthodontic treatment,and/or for the relief ofbruxism or snoring. Thedevice is used inconjunction with a | Different |
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Reference DeviceKeyPrint KeySplint Soft | Secondary Reference DeviceLuxaPrint Ortho Plus | SubstantialEquivalenceComparisonAssessment |
| compatible scanner, 3Dprinter, and curing unit. | ||||
| Method ofUse | Each preformed plastic tray isworn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using the nextsequential aligner tray | Dental office/clinic, dental laboratoryfor appliance design and fabrication;home use for the resulting dentalappliance. | Dental office/clinic, dentallaboratory for appliancedesign and fabrication; homeuse for the resulting dentalappliance. | Different |
| OTC/Rx | Rx | Rx | Rx | Same |
| Software Usedfor OrderingWorkflow | Yes, a software is involvedduring the manufacturingordering and manufacturingprocess.This device does not containSoftware. | Yes, a software is involved during themanufacturing ordering andmanufacturing process.This device does not containSoftware. | Yes, a software is involvedduring the manufacturingordering and manufacturingprocess.This device does not containSoftware. | Same |
| Biocompatibility | ISO 10993-3:2014Genotoxicity testISO 10993-5 In vitroCytotoxicityISO 10993-6 Subchronicsystemic toxicityISO 10993-10 Oral MucosaIrritationPyrogenISO 10993-10 Skin Irritation inRabbitsISO 10993-10 SkinSensitization in Guinea Pigs | ISO 10993-5 CytotoxicityISO 10993-10 SensitizationISO 10993-10 Irritation | ISO 10993-1BiocompatibilityAssessmentISO 10993-5 CytotoxicityISO 10993-10 IrritationISO 10993-10SensitizationISO 10993-3 Genotoxicity | Equivalent |
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Reference DeviceKeyPrint KeySplint Soft | Secondary Reference DeviceLuxaPrint Ortho Plus | SubstantialEquivalenceComparisonAssessment |
| (Maximization Test)ISO 10993-11 Acute SystemicToxicityISO 10993-11 Subchronicsystemic toxicity | ||||
| Material | Light-cured polyurethane resin | Light-cured polyurethane resin | Photocurable (meth)-acrylate-based polymerresin | Equivalent |
| Design | G2Image: Clear aligner | Image: Clear aligner | Image: Clear aligner | Similar |
Substantial Equivalence Comparison Table-Reference Devices-Basic Information 0.
SECTION 5-510(k) SUMMARY Page 8 of 14 pages
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(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com
SECTION 5-510(k) SUMMARY
Page 9 of 14 pages
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(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com
SECTION 5-510(k) SUMMARY
Page 10 of 14 pages
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(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com
Substantial Equivalence Comparison Table- Reference Devices-Manufacturing Information: P.
| Items | Proposed DeviceLuxCreo Clear AlignerSystem | Primary Reference DeviceKeyPrint KeySplint SoftK183598 | Secondary Reference DeviceLuxaPrint Ortho PlusK210940 | SubstantialEquivalenceComparisonAssessment |
|---|---|---|---|---|
| Method ofManufacturing | Light-cured 3 D printing | Light-cured 3 D printing | Light-cured 3 D printing | Same |
| TechnicalSpecifications of3D printing | DLP/ SLA 3D printer UVcured 3D printing resin formedical device manufacturing. | DLP/ SLA 3D printer UV cured 3Dprinting resin for medical devicemanufacturing. | DLP/ SLA 3D printer UVcured 3D printing resin formedical device manufacturing. | Same |
SECTION 5-510(k) SUMMARY
Page 11 of 14 pages
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(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com
| Items | Proposed DeviceLuxCreo Clear AlignerSystem | Primary Reference DeviceKeyPrint KeySplint SoftK183598 | Secondary Reference DeviceLuxaPrint Ortho PlusK210940 | SubstantialEquivalenceComparisonAssessment |
|---|---|---|---|---|
| Manufacturingprocessworkflow | The raw 3D printing material incombination with LuxCreo'smanufacturing system. | Raw 3D printing material | Raw 3D printing material | Different |
Q. Substantial Equivalence Comparison Table-Physical and Mechanical Properties
| Items | Proposed DeviceLuxCreo Clear Aligner System | Primary Reference DeviceKeyPrint KeySplint SoftK183598 | Secondary Reference DeviceLuxaPrint Ortho PlusK210940 | SubstantialEquivalenceComparisonAssessment |
|---|---|---|---|---|
| Flexural Strength | 40.02±0.08 MPa (ASTM D790)23.6 ± 1.9 MPa (ISO 20795-2:2013) | 44-47 MPa (ASTM D790) | 80 – 93 MPa (385 nm)77 - 90 MPa (405 nm)(ISO 4049 & ISO 20795-2) | Different |
| FlexuralModulus | 1106.47±13.23 MPa (ASTM D790)804 ± 64 MPa (ISO 20795-2:2013) | 1100-1400 MPa (ASTM D790)135-200 MPa (ISO 20795-2) | 1.9 - 2.4 GPa (385 nm)2.1 - 2.5 GPa (405 nm)(ISO 4049 & ISO 20795-2) | Different |
| Shore DHardness | 21.63±0.38 HD | 80-85 MPa (ASTM D2240) | ≥ 60 (Cured material) | Different |
| Ultimate FlexuralStrength | Ultimate flexural strength is23.6 ± 1.9 MPa. | 2.6—4.4 MPa (ISO 20795-2) | N/A | Different |
| Water Solubility | 3.668±1.0748 µg/mm³ | 4.8 µg/mm³ | 1.5 - 3.6 µg/mm³ (385 nm)0.7 - 2.1 µg/mm³ (405 nm)(ISO 4049 & ISO 20795-2) | Different |
| Water Sorption | 19.952±6.6719 µg/mm³ | 18 µg/mm³ | 18.6 – 20.3 (385 nm)17.1 - 17.7 µg/mm³ (405nm)(ISO 4049 & ISO 20795-2) | Similar |
SECTION 5-510(k) SUMMARY
Page 12 of 14 pages
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Image /page/15/Picture/0 description: The image shows the logo for LuxCreo. The logo is in a sans-serif font, with the "X" in "Lux" being orange and the rest of the letters being black. The logo is simple and modern.
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R. SUMMARY OF PERFORMANCE DATA
The following performance data were provided to demonstrate the safetv and efficacy: -
A. ISO 10993-3:2014 Genotoxicity test
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ISO 10993-5 In vitro C vtotoxicitv B.
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ISO 10993-6:2016 Subcutaneous Implantation Test C.
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D. ISO 10993-10 Oral Mucosa Irritation
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USP Pyrogen Study E.
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ISO 10993-10 Skin Irritation F.
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G. ISO 10993-10 Skin Sensitization (Maximization Test)
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ISO 10993-11 Acute Systemic Toxicity H.
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I. ISO 10993-11:2017 Sub-chronic systemic toxicity
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J. Transportation and accelerating ageing tests were validated and completed.
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Physical, chemical and mechanical properties were tested. K.
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Design verification, validation and manufacturing validation L. were completed. All the results meet the product specification requirements.
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છ SUBSTANTIAL EQUIVALENCE CONCLUSION
LuxCreo Clear Aligner System, ULab Systems Dental Aligner Kit, and the ClearCorrect System are intended to provide force to the user's teeth gently, and in small increments, from their original misalignment to their final treated position, for improved dental alignment. The difference in manufacturing process and base materials have not raised extra safety and performance concerns, based on the relevant tests and evaluations provided in this submission.
Both KeyPrint KeySplint Soft, K183598, and LuxaPrint Ortho Plus, K210940, are using DLP/ SLA 3D printer with UV cured 3D printing resin for the intended use of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. The additive manufacturing and based materials used for the LuxCreo Clear Aligner System and reference devices are substantially equivalent without extra concerns on their difference of properties.
Based upon the information presented in this section, LUXCREO INC. concludes that the LuxCreo Clear Aligner System is
SECTION 5-510(k) SUMMARY Page 13 of 14 pages
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Image /page/16/Picture/0 description: The image shows the logo for LuxCreo. The logo is in a sans-serif font, with the letters in black except for the 'X', which is orange. The logo is simple and modern.
substantially equivalent to predicate devices in regard to indications for use, design, and technology.
SECTION 5-510(k) SUMMARY Page 14 of 14 pages
§ 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.