(280 days)
No
The provided text describes a clear aligner system that uses 3D printing based on a predetermined shape. There is no mention of AI or ML being used in the design, planning, or manufacturing process. The "Not Found" entries for "Mentions AI, DNN, or ML", "Description of the training set...", and "Description of the test set..." further support this conclusion.
Yes
The device is used for the treatment of tooth malocclusion by repositioning teeth using gentle force.
No
Explanation: The device is a system of clear aligners used to reposition teeth, which is a treatment for malocclusion. It does not perform diagnostic functions but rather therapeutic ones.
No
The device description explicitly states it is a "custom plastic aligner system" which are physical, removable aligners. It also mentions a 3D printer and UV-light curing box as part of the manufacturing process, indicating hardware components are integral to the device.
Based on the provided information, the LuxCreo Clear Aligner System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LuxCreo Clear Aligner System Function: The LuxCreo Clear Aligner System is a physical device used to mechanically reposition teeth. It does not involve testing biological samples from the patient.
- Intended Use: The intended use is for the "treatment of tooth malocclusion," which is a physical correction, not a diagnostic test.
- Device Description: The description details a physical aligner system, 3D printing, and materials, all related to a physical treatment device.
- Performance Studies: The performance studies listed are primarily biocompatibility and physical property tests, which are relevant for a medical device that comes into contact with the body, but not for an IVD.
Therefore, the LuxCreo Clear Aligner System falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
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 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.
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 / dental office/clinic
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 the safety and efficacy:
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 Irritation
G. ISO 10993-10 Skin Sensitization (Maximization Test)
H. ISO 10993-11 Acute Systemic Toxicity
I. ISO 10993-11:2017 Sub-chronic systemic toxicity
J. Transportation and accelerating ageing tests were validated and completed.
K. Physical, chemical and mechanical properties were tested.
L. Design verification, validation and manufacturing validation were completed. All the results meet the product specification requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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) | |
|---|---|
| ☑ 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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.
-
- 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
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
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
SECTION 5-510(k) SUMMARY
Page 9 of 14 pages
12
(650) 336-0888 940 Old County Road, Belmont, CA 94002 www.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
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
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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.
-
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
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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.