Who is the manufacturer of LuxCreo Clear Aligner System?

LuxCreo, Inc. filed the 510(k) submission for LuxCreo Clear Aligner System (K212680).

What is the FDA product code for LuxCreo Clear Aligner System?

NXC. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for LuxCreo Clear Aligner System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LuxCreo Clear Aligner System?

ULab Systems Dental Aligner Kit (K192596); ClearCorrect System (K113618).

Who can help prepare an FDA 510(k) submission like LuxCreo Clear Aligner System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LuxCreo Clear Aligner System

K212680 · LuxCreo, Inc. · NXC · May 31, 2022 · Dental

Device Facts

Record ID	K212680
Device Name	LuxCreo Clear Aligner System
Applicant	LuxCreo, Inc.
Product Code	NXC · Dental
Decision Date	May 31, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

The LuxCreo Clear Aligner System consists of a series of custom, removable, clear plastic aligners designed to reposition teeth through continuous gentle force. The system is prescribed by dental health professionals. The manufacturing process utilizes 3D stereolithographic printing with specialty liquid polyurethane resins; printed aligners undergo UV-light curing to achieve final mechanical properties. Aligners are packaged in a specific sequence for patient use, typically worn 20-22 hours per day. The device is used in a clinical/home context where the physician manages the treatment plan and the patient wears the aligners to achieve incremental tooth movement. The system relies on software for the ordering and manufacturing workflow to translate the prescribed tooth displacement into the physical aligner design.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-3, -5, -6, -10, -11, USP Pyrogen), physical/mechanical property testing (flexural strength, modulus, hardness, stress relaxation, water solubility/sorption), and design verification/validation.

Technological Characteristics

Light-cured polyurethane resin; additive manufacturing via DLP/SLA 3D printing; UV-cured; removable aligner form factor; prescription use; software-assisted ordering/manufacturing workflow. Biocompatibility per ISO 10993 standards. Mechanical properties: Flexural Strength 23.6 ± 1.9 MPa (ISO 20795-2:2013); Flexural Modulus 1106.47±13.23 MPa (ASTM D790).

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

ULab Systems Dental Aligner Kit (K192596)
ClearCorrect System (K113618)

Reference Devices

KeyPrint KeySplint Soft (K183598)
LuxaPrint Ortho Plus (K210940)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;"> ☑ </div> Prescription Use (Part 21 CFR 201 Subpart D) </div> | | | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;"> ☐ </div> Over-The-Counter Use (21 CFR 201.66) </div> | | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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, and the colors are eye-catching. ### 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 94002 Registration Number: 3016237718 FEI Number: 3016237718 Tel:+1 650-3360227 | | D. | CONTACT PERSON Primary Contact Person C.O.O. Mike Yang +1 650-336-0888 Mike.yang@luxcreo.com Second Contact Project Manager Jethro Wu 0970532485 Jethro.Wu@LuxCreo.com | | E. | DEVICE Proprietary Name: LuxCreo Clear Aligner System Common Name: Aligner, Sequential Product Code: NXC Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Device Class: Class II 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). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for LuxCreo. The logo is black, except for the X, which is orange. The logo is simple and modern. | G. | PRIMARY PREDICATE 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 Kit Sequential Aligner NXC 21 CFR 872.5470 Orthodontic Plastic Bracket K192596 uLab Systems, Inc. Class II Dental | |----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | H. | SECONDARY PREDICATE DEVICE | Proprietary Name: Common Name: Product Code: Regulation Number: Regulation Name: 510(k) Number: 510(k) Submitter: Device Class: Review Panel: | ClearCorrect System Sequential Aligner NXC 21 CFR 872.5470 Orthodontic Plastic Bracket K113618 ClearCorrect LLC Class II Dental | | I. | PRIMARY REFERNCE DEVICE | Proprietary Name: Common Name: Regulation Number: Classification Product Code: Subsequent Product Code: 510(k) Number: 510(k) Submitter: Device Class: Review Panel: | KeyPrint KeySplint Soft Mouthguard, Prescription/ Positioner, Tooth, Preformed No associated regulation/ 21 CFR 872.5525 MQC KMY K183598 Keystone Industries Unclassified, Class I Dental | | J. | SECONDARY REFERENCE DEVICE | Proprietary Name: Common Name: Regulation Number: | LuxaPrint Ortho Plus Prescription Mouthguard/ Resin, Denture, Relining, Repairing, Rebasing No associated regulation/ 21 CFR 872.3760 | SECTION 5-510(k) SUMMARY Page 2 of 14 pages {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for LuxCreo. The logo is black, except for the X, which is orange. The text is sans-serif and bolded. | 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for LUXCreo. The word "Lux" is in black font, with the "X" in orange. The word "Creo" is in black font. 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. - 7. Removable devices - 8. Different manufacturing process - 9. 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 - 3. 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 {7}------------------------------------------------ Image /page/7/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. > 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 {8}------------------------------------------------ (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 Device LuxCreo Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit | Secondary Predicate Device ClearCorrect System | Substantial Equivalence Comparison Assessment | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | 510(k) Number Product Code Device Classification | TBD NXC Class II | K192596 NXC Class II | K113618 NXC Class II | N/A Same Same | | Intended Use/ 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. | The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces. | The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent.dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force. | Same | | Mode of Action | Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays | Each preformed plastic tray is worn in sequence by the patient as prescribed by the dental practitioner. Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription. | Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays | Same | | Method of Use | Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next | During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to | Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next | Same | | Items | Proposed Device LuxCreo Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit | Secondary Predicate Device ClearCorrect System | Substantial Equivalence Comparison Assessment | | | 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 for approximately 2 weeks of 20-22 hours of wear per day or according to doctor's prescription. | 20-22 hours/day | Same | | Method of Manufacturing | Light-cured 3 D printing | Thermoforming | Thermoforming | Different | | Software Used for Ordering Workflow | Yes | Yes | Yes | Same | | Application | Removable | Removable | Removable | Same | | Biocompatibility | ISO 10993-5 In vitro Cytotoxicity ISO 10993-10 Oral Mucosa Irritation Pyrogen ISO 10993-10 Skin Irritation in Rabbits ISO 10993-10 Skin Sensitization in Guinea Pigs (Maximization Test) ISO 10993-11 Acute Systemic Toxicity | Raw materials: Cytotoxicity Elution -MEM Intracutaneous/Intradermal Reactivity Maximization for Delayed-Type Hypersensitivity Oral Mucosa Irritation Test Final product: Cytotoxicity Elution -MEM | ISO 10993-5 Cytotoxicity ISO 10993-10 Intracutaneous reactivity, oral mucosa irritation test, maximization test for delayed type hypersensitivity | Similar | | Material | Light-cured polyurethane resin | Zendura A (thin thermoformed polyurethane) or Zendura FLX (copolyester and polyurethane composite) | Thermoplastic polyurethane resin | Different | | Items | Proposed Device LuxCreo Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit | Secondary Predicate Device ClearCorrect System | Substantial Equivalence Comparison Assessment | | Design | Image: LuxCreo Clear Aligner System labeled G2 | Image: ULab Systems Dental Aligner Kit | Image: ClearCorrect System | Similar design | SECTION 5-510(k) SUMMARY Page 6 of 14 pages {9}------------------------------------------------ ### (650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com ### SECTION 5-510(k) SUMMARY Page 7 of 14 pages {10}------------------------------------------------ ### 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 Device LuxCreo Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit K192596 | Secondary Predicate Device ClearCorrect System K113618 | Substantial Equivalence Comparison Assessment | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Ultimate Flexural Strength | 23.6 ± 1.9 MPa | N/A | 36.8±1.1 MPa (ISO 20795-2:2013) | Different | | Flexural Modulus | 1106.47±13.23 MPa (ASTM D790) 804 ± 64 MPa (ISO 20795- 2:2013) | N/A | 1122±24 MPa (ISO 20795-2:2013) | Different | | Shore D Hardness | 21.63±0.38 HD | N/A | 21.33±0.06 HD | Similar | | Stress Relaxation | 37.3 ± 0.3% No cracking was found. | N/A | 25.5 ± 0.4% No cracking was found. | Different | | Items | Proposed Device LuxCreo Clear Aligner System | Primary Reference Device KeyPrint KeySplint Soft | Secondary Reference Device LuxaPrint Ortho Plus | Substantial Equivalence Comparison Assessment | | 510(k) Number | TBD | K183598 | K210940 | N/A | | Product Code | NXC | MQC/ KMY | MQC/ EBI | Different | | Device Classification | Class II | Unclassified/ Class II | Unclassified/ Class II | Different | | Intended Use/ 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. | The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. | For the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and positioners. The product is for use with DLP/SLA printers that work at wavelengths of 385 nm or 405 nm. | Different | | Mode of Action | Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays | It depends on the indications of final device. | The device consists of raw material that is used to fabricate removable custom dental appliances, such as orthodontic splints and/or mouthguards. The finished devices can be used to support tooth stabilization following active orthodontic treatment, and/or for the relief of bruxism or snoring. The device is used in conjunction with a | Different | | Items | Proposed Device LuxCreo Clear Aligner System | Primary Reference Device KeyPrint KeySplint Soft | Secondary Reference Device LuxaPrint Ortho Plus | Substantial Equivalence Comparison Assessment | | | | | compatible scanner, 3D printer, and curing unit. | | | Method of Use | 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 aligner tray | Dental office/clinic, dental laboratory for appliance design and fabrication; home use for the resulting dental appliance. | Dental office/clinic, dental laboratory for appliance design and fabrication; home use for the resulting dental appliance. | Different | | OTC/Rx | Rx | Rx | Rx | Same | | Software Used for Ordering Workflow | Yes, a software is involved during the manufacturing ordering and manufacturing process. This device does not contain Software. | Yes, a software is involved during the manufacturing ordering and manufacturing process. This device does not contain Software. | Yes, a software is involved during the manufacturing ordering and manufacturing process. This device does not contain Software. | Same | | Biocompatibility | ISO 10993-3:2014 Genotoxicity test ISO 10993-5 In vitro Cytotoxicity ISO 10993-6 Subchronic systemic toxicity ISO 10993-10 Oral Mucosa Irritation Pyrogen ISO 10993-10 Skin Irritation in Rabbits ISO 10993-10 Skin Sensitization in Guinea Pigs | ISO 10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-10 Irritation | ISO 10993-1 Biocompatibility Assessment ISO 10993-5 Cytotoxicity ISO 10993-10 Irritation ISO 10993-10 Sensitization ISO 10993-3 Genotoxicity | Equivalent | | Items | Proposed Device LuxCreo Clear Aligner System | Primary Reference Device KeyPrint KeySplint Soft | Secondary Reference Device LuxaPrint Ortho Plus | Substantial Equivalence Comparison Assessment | | | (Maximization Test) ISO 10993-11 Acute Systemic Toxicity ISO 10993-11 Subchronic systemic toxicity | | | | | Material | Light-cured polyurethane resin | Light-cured polyurethane resin | Photocurable (meth)- acrylate-based polymer resin | Equivalent | | Design | G2 Image: 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 {11}------------------------------------------------ ### (650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com ### SECTION 5-510(k) SUMMARY Page 9 of 14 pages {12}------------------------------------------------ ### (650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com ### SECTION 5-510(k) SUMMARY Page 10 of 14 pages {13}------------------------------------------------ ### (650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com #### Substantial Equivalence Comparison Table- Reference Devices-Manufacturing Information: P. | Items | Proposed Device LuxCreo Clear Aligner System | Primary Reference Device KeyPrint KeySplint Soft K183598 | Secondary Reference Device LuxaPrint Ortho Plus K210940 | Substantial Equivalence Comparison Assessment | |-----------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------| | Method of Manufacturing | Light-cured 3 D printing | Light-cured 3 D printing | Light-cured 3 D printing | Same | | Technical Specifications of 3D printing | DLP/ SLA 3D printer UV cured 3D printing resin for medical device manufacturing. | DLP/ SLA 3D printer UV cured 3D printing resin for medical device manufacturing. | DLP/ SLA 3D printer UV cured 3D printing resin for medical device manufacturing. | Same | ### SECTION 5-510(k) SUMMARY Page 11 of 14 pages {14}------------------------------------------------ (650) 336-0888 940 Old County Road, Belmont, CA 94002 www.luxcreo.com info@luxcreo.com | Items | Proposed Device LuxCreo Clear Aligner System | Primary Reference Device KeyPrint KeySplint Soft K183598 | Secondary Reference Device LuxaPrint Ortho Plus K210940 | Substantial Equivalence Comparison Assessment | |--------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------| | Manufacturing process workflow | The raw 3D printing material in combination with LuxCreo's manufacturing system. | Raw 3D printing material | Raw 3D printing material | Different | #### Q. Substantial Equivalence Comparison Table-Physical and Mechanical Properties | Items | Proposed Device LuxCreo Clear Aligner System | Primary Reference Device KeyPrint KeySplint Soft K183598 | Secondary Reference Device LuxaPrint Ortho Plus K210940 | Substantial Equivalence Comparison Assessment | |-------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------| | 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 | | Flexural Modulus | 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 D Hardness | 21.63±0.38 HD | 80-85 MPa (ASTM D2240) | ≥ 60 (Cured material) | Different | | Ultimate Flexural Strength | Ultimate flexural strength is 23.6 ± 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 {15}------------------------------------------------ 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. - R. SUMMARY OF PERFORMANCE DATA The following performance data were provided to demonstrate the safetv and efficacy: - A. ISO 10993-3:2014 Genotoxicity test - ISO 10993-5 In vitro C vtotoxicitv B. - ISO 10993-6:2016 Subcutaneous Implantation Test C. - D. ISO 10993-10 Oral Mucosa Irritation - USP Pyrogen Study E. - ISO 10993-10 Skin Irritation F. - G. ISO 10993-10 Skin Sensitization (Maximization Test) - ISO 10993-11 Acute Systemic Toxicity H. - I. ISO 10993-11:2017 Sub-chronic systemic toxicity - J. Transportation and accelerating ageing tests were validated and completed. - Physical, chemical and mechanical properties were tested. K. - Design verification, validation and manufacturing validation L. were completed. All the results meet the product specification requirements. - 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 {16}------------------------------------------------ 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

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