(158 days)
("K201173")
None
No
The summary describes a photocurable polymer resin for 3D printing dental appliances and does not mention any AI or ML components in the material or the fabrication process described.
Yes
The device is a material used to fabricate orthodontic and dental appliances such as mouthguards and splints. These appliances are used to treat conditions like bruxism and teeth grinding, which are therapeutic uses.
No
Explanation: The device is a photocurable polymer resin used for fabricating orthodontic and dental appliances. It does not perform any diagnostic function.
No
The device is a photocurable polymer resin used in a 3D printing process to fabricate physical dental appliances. It is a material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is the "Fabrication of orthodontic and dental appliances such as mouthguards, splints and positioners." This describes a manufacturing process for a medical device that is placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a "photocurable polymer resin indicated for use for the fabrication of orthodontic and dental appliances." It's a material used to create a physical device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
- Measuring biomarkers
The device is a material used in the manufacturing of a medical device (orthodontic and dental appliances). While these appliances are used for medical purposes (treating bruxism, stabilizing teeth), the resin itself is not performing a diagnostic test.
N/A
Intended Use / Indications for Use
Fabrication of orthodontic and dental appliances such as mouthguards, splints and positioners.
The product is for use with DLP / SLA printers that work at wavelengths of 385 nm or 405 nm.
Product codes
MQC, EBI
Device Description
LuxaPrint Ortho Plus is a (meth)acrylate-based photocurable polymer resin indicated for use for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and positioners, using a 3D printing process. LuxaPrint Ortho Plus material is used in a dental laboratory to fabricate a removable custom dental appliance. LuxaPrint Ortho Plus will be available in two variants matched to the operating wavelength of the 3D printer (385 nm and 405 nm). LuxaPrint Ortho Plus is used in conjunction with a compatible dental scanner, 3D printer, and curing equipment. Typical medical indications include bruxism and teeth grinding, or stabilization of the tooth's position after active orthodontic treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental office/clinic, dental laboratory for appliance design and fabrication; home use for the resulting dental appliance.
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)
Performance data demonstrated that finished devices manufactured using the LuxaPrint Ortho Plus material meet all predetermined acceptance criteria contained in the product specification and are suitable for use in the fabrication of reusable orthodontic splints and mouthguards. 3D printed devices fabricated using LuxaPrint Ortho Plus have been tested for and found to have comparable physical properties appropriate for removable dental appliances flexural strength, flexural modulus, water solubility, and water sorption. The risks associated with the use of the new devices were found acceptable when evaluated in accordance with ISO 14971. Risks and benefits associated with the proposed and the predicate device are the same. Design verification and validation activities consisted of physical testing, biocompatibility evaluation, and stability (shelf life) validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Water Solubility: 1.5 – 3.6 µg/mm³ (385 nm), 0.7 - 2.1 µg/mm³ (405 nm)
- Water Sorption: 18.6 – 20.3 (385 nm), 17.1 – 17.7 µg/mm³ (405 nm)
- Flexural Strength: 80 – 93 MPa (385 nm), 77 - 90 MPa (405 nm)
- Flexural Modulus: 1.9 - 2.4 GPa (385 nm), 2.1 - 2.5 GPa (405 nm)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.
September 3, 2021
DMG Digital Enterprises SE % Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, Massachusetts 01432
Re: K210940
Trade/Device Name: LuxaPrint Ortho Plus Regulatory Class: 21 CFR 872.3760 Product Code: MQC, EBI Dated: June 7, 2021 Received: June 8, 2021
Dear Pamela Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210940
Device Name
LuxaPrint Ortho Plus
Indications for Use (Describe)
Fabrication of orthodontic and dental appliances such as mouthguards, splints and positioners.
The product is for use with DLP / SLA printers that work at wavelengths of 385 nm or 405 nm.
| answers and more for the commend of production of the model of consistence many of the many consistence in the many of the many comments of the comments of the comments of th | |
|---|---|
| Type of Use (Select one or both, as applicable) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Attachment C - LuxaPrint Ortho Plus 510(k) Summary
General Information
| Preparation date: | 02 September 2021 |
|---|---|
| Owner's Name: | DMG Dental Enterprises SE |
| (FDA Registration 3012623144) | |
| Address: | Elbgaustrasse 248 |
| 22547 Hamburg | |
| Germany | |
| Telephone Number: | 011-49-40-84006-0 |
| Fax Number: | 011-49-40-84006-222 |
| Contact Person: | Stephan Schaefer |
| Subject Device Name: | LuxaPrint Ortho Plus |
| Trade Name: | LuxaPrint Ortho Plus |
| Common/Usual Name: | Prescription Mouthguard |
| Product Code; Regulation: | MQC (Mouthguard, Prescription); no associated regulation |
| EBI (Resin, Denture, Relining, Repairing, Rebasing); | |
| 21 CFR 872.3760 | |
| Device Classification: | Unclassified |
| Primary Predicate Device: | |
| Trade Name: | EnvisionTEC GmbH E-Guard |
| Common/Usual Name: | Prescription Mouthguard |
| Product Code; Regulation: | MQC (Prescription Mouthguard); no associated regulation |
| EBI (Resin, Denture, Relining, Repairing, Rebasing); | |
| 21 CFR 872.3760 | |
| Device Classification: | Unclassified |
| Premarket Notification: | K201173, SE date 27 November 2020 |
Device Description
LuxaPrint Ortho Plus is a (meth)acrylate-based photocurable polymer resin indicated for use for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and positioners, using a 3D printing process. LuxaPrint Ortho Plus material is used in a dental laboratory to fabricate a removable custom dental appliance. LuxaPrint Ortho Plus will be available in two variants matched to the operating wavelength of the 3D printer (385 nm and 405 nm). LuxaPrint Ortho Plus is used in conjunction with a compatible dental
4
scanner, 3D printer, and curing equipment. Typical medical indications include bruxism and teeth grinding, or stabilization of the tooth's position after active orthodontic treatment.
Indications for Use
For the fabrication of orthodontic and dental appliances such as mouthguards, splints and positioners. The product is for use with DLP/SLA printers that work at wavelengths of 385 nm or 405 nm.
Substantial Equivalence / Comparison of Technical Characteristics with the Predicate Device
The predicate device is the EnvisionTEC GmbH E-Guard cleared in K201173. A summary comparison of the subject and predicate device systems is provided in the substantial equivalence table below.
| Attribute | Proposed Device
DMG Digital Enterprises
SE LuxaPrint Ortho Plus
(current submission) | Predicate Device
EnvisionTEC GmbH
E-Guard
(K201173) | Similarities and
Differences |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Common Name | Prescription Mouthguard | Prescription Mouthguard | Same |
| Classification
Name | Unclassified | Unclassified | Same |
| Device Class | Unclassified | Unclassified | Same |
| Regulation | N/A, 21 CFR 872.3760 | N/A, 21 CFR 872.3760 | Same |
| Regulation
Name | Mouthguard, Prescription
Resin, Denture, Relining,
Repairing, Rebasing | Mouthguard, Prescription
Resin, Denture, Relining,
Repairing, Rebasing | Same |
| Product Code | MQC, EBI | MQC, EBI | Same |
| Indications
for Use | 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. | EnvisionTEC's E-Guard is
a light-cured resin. It is a
polymer used to create
removable structures for
therapeutic restorations,
i.e., bite guards/splints and
occlusal night guard/splints
using the Additive
Manufacturing process.
The resin in combination
with a scanner, printer, and
curing unit make up the
system. | Same with wording
differences |
| Attribute | Proposed Device
DMG Digital Enterprises
SE LuxaPrint Ortho Plus
(current submission) | Predicate Device
EnvisionTEC GmbH
E-Guard
(K201173) | Similarities and
Differences |
| Use
Environment | 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. | Same |
| Material
Composition | Photocurable (meth)-
acrylate-based polymer
resin | Photocurable (meth)-
acrylate-based polymer
resin | Same |
| Principle of
Operation | 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
compatible scanner, 3D
printer, and curing unit. | 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
compatible scanner, 3D
printer, and curing unit. | Same |
| Water Solubility | 1.5 – 3.6 $ µg/mm³ $ (385 nm)
0.7 - 2.1 $ µg/mm³ $ (405 nm) | 0.5 $ µm/mm³ $ | Equivalent; both
meet ISO 4049 &
ISO 20795-2
requirements |
| Water Sorption | 18.6 – 20.3 (385 nm)
17.1 – 17.7 $ µg/mm³ $ (405
nm) | 37 $ µm/mm³ $ | Equivalent; both
meet ISO 4049 &
ISO 20795-2
requirements |
| Flexural
Strength | 80 – 93 MPa (385 nm)
77 - 90 MPa (405 nm) | 79 – 85 MPa | Equivalent; both
meet ISO 4049 &
ISO 20795-2
requirements |
| Flexural
Modulus | 1.9 - 2.4 GPa (385 nm)
2.1 - 2.5 GPa (405 nm) | 2052 - 2130 MPa | Equivalent; both
meet ISO 4049 &
ISO 20795-2
requirements |
| | Proposed Device | Predicate Device | Similarities and |
| Attribute | DMG Digital Enterprises
SE LuxaPrint Ortho Plus | EnvisionTEC GmbH
E-Guard | Differences |
| | (current submission) | (K201173) | |
| Biocompatibility | ISO 10993 | ISO 10993-1
Biocompatibility
Assessment
ISO 10993-5 Cytotoxicity
ISO 10993-10 Irritation
ISO 10993-10
Sensitization
ISO 10993-3 Genotoxicity | Equivalent |
| Single Use /
Reusable | Single Use | Single Use | Same |
| Sterilization /
Reprocessing | Non-sterile device; no
reprocessing requirements | Non-sterile device; no
reprocessing requirements | Same |
| Software | Device does not contain
software | Device does not contain
software | Same |
| Electrical Safety
& EMC | Not applicable | Not applicable | Same |
| Compatible 3D
Printer Type | DLP / SLA operating at 385
nm or 405 nm | DLP / SLA operating at 385
nm | Different |
Substantial Equivalence Comparison Table
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Non-clinical Performance Testing
Performance data demonstrated that finished devices manufactured using the LuxaPrint Ortho Plus material meet all predetermined acceptance criteria contained in the product specification and are suitable for use in the fabrication of reusable orthodontic splints and mouthguards. 3D printed devices fabricated using LuxaPrint Ortho Plus have been tested for and found to have comparable physical properties appropriate for removable dental appliances flexural strength, flexural modulus, water solubility, and water sorption. The risks associated with the use of the new devices were found acceptable when evaluated in accordance with ISO 14971. Risks and benefits associated with the proposed and the predicate device are the same. Design verification and validation activities consisted of physical testing, biocompatibility evaluation, and stability (shelf life) validation.
Comparison of Technological Characteristics with the Predicate Device
The intended use, performance specifications, and additive method of manufacturing of LuxaPrint Ortho Plus are substantially equivalent to the predicate device, E-Guard. While the specific resin formulation of the predicate is different from LuxaPrint Ortho Plus, both are (meth)acrylate-based photo-curable resins used in additive manufacturing and are of the same material category. The additive manufacturing processes both use a resin, scanner, printer, and curing unit. The testing performed on LuxaPrint Ortho Plus produced results similar to data reported for the predicate device. Although the wording is not identical, the indications for use
7
for LuxaPrint Ortho Plus are equivalent to those of the predicate E-Guard in that both devices are intended for the fabrication of removable dental appliances such as mouthguards, nightguards, splints, and positioners. The LuxaPrint Ortho Indications for Use further state "the product is for use with DLP / SLA printers that work at wavelengths of 385 nm or 405 nm," while the predicate Indications for Use states "the resin in combination with a scanner, printer, and curing unit make up the system". The specific 3D printer units recommended for use with LuxaPrint Ortho Plus are prominently identified in the device Instructions for Use. The predicate device Indications for Use statement identifies E-Guard as "a light-cured resin". The same information is presented in the LuxaPrint Ortho Plus Instructions for Use under the heading "Product Description." These minor differences do not adversely affect substantial equivalence.
Conclusion
The DMG Dental Enterprises SE LuxaPrint Ortho Plus meets all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence to the predicate device.