LuxaPrint Ortho Plus

K210940 · Dmg Digital Enterprises SE · MQC · Sep 3, 2021 · DE

Device Facts

• Record ID: K210940
• Device Name: LuxaPrint Ortho Plus
• Applicant: Dmg Digital Enterprises SE
• Product Code: MQC · DE
• Decision Date: Sep 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

LuxaPrint Ortho Plus is a (meth)acrylate-based photocurable polymer resin used in dental laboratories to fabricate custom removable dental appliances via 3D printing (DLP/SLA). The system requires a compatible dental scanner, 3D printer (385 nm or 405 nm), and curing equipment. The resin is processed into physical appliances used by patients to manage bruxism, teeth grinding, or for post-orthodontic stabilization. The healthcare provider designs the appliance digitally and oversees the fabrication process. The final appliance provides mechanical support to the patient's dentition, benefiting the patient by protecting teeth from grinding forces or maintaining orthodontic alignment.

Clinical Evidence

Bench testing only. No clinical data. Performance testing confirmed physical properties (flexural strength, flexural modulus, water solubility, water sorption) meet ISO 4049 and ISO 20795-2 standards. Biocompatibility evaluated per ISO 10993. Risk management performed per ISO 14971.

Technological Characteristics

(Meth)acrylate-based photocurable polymer resin; additive manufacturing (DLP/SLA); compatible with 385 nm or 405 nm light sources; non-sterile; single-use. Physical properties meet ISO 4049 and ISO 20795-2. No software, electronics, or EMC requirements.

Indications for Use

Indicated for fabrication of orthodontic and dental appliances including mouthguards, nightguards, splints, and positioners for patients requiring bruxism relief, teeth grinding management, or stabilization of tooth position post-orthodontic treatment.

Predicate Devices

• EnvisionTEC GmbH E-Guard (K201173)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

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 | |
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| 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)

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### Attachment C - LuxaPrint Ortho Plus 510(k) Summary

#### General Information

| Preparation date: | 02 September 2021 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Owner's Name: | DMG Dental Enterprises SE<br>(FDA Registration 3012623144) |
| Address: | Elbgaustrasse 248<br>22547 Hamburg<br>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<br>EBI (Resin, Denture, Relining, Repairing, Rebasing);<br>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<br>EBI (Resin, Denture, Relining, Repairing, Rebasing);<br>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

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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<br>DMG Digital Enterprises<br>SE LuxaPrint Ortho Plus<br>(current submission) | Predicate Device<br>EnvisionTEC GmbH<br>E-Guard<br>(K201173) | Similarities and<br>Differences |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Common Name | Prescription Mouthguard | Prescription Mouthguard | Same |
| Classification<br>Name | Unclassified | Unclassified | Same |
| Device Class | Unclassified | Unclassified | Same |
| Regulation | N/A, 21 CFR 872.3760 | N/A, 21 CFR 872.3760 | Same |
| Regulation<br>Name | Mouthguard, Prescription<br>Resin, Denture, Relining,<br>Repairing, Rebasing | Mouthguard, Prescription<br>Resin, Denture, Relining,<br>Repairing, Rebasing | Same |
| Product Code | MQC, EBI | MQC, EBI | Same |
| Indications<br>for Use | Fabrication of orthodontic<br>and dental appliances such<br>as mouthguards,<br>nightguards, splints and<br>positioners. The product is<br>for use with DLP / SLA<br>printers that work at<br>wavelengths of 385 nm or<br>405 nm. | EnvisionTEC's E-Guard is<br>a light-cured resin. It is a<br>polymer used to create<br>removable structures for<br>therapeutic restorations,<br>i.e., bite guards/splints and<br>occlusal night guard/splints<br>using the Additive<br>Manufacturing process.<br>The resin in combination<br>with a scanner, printer, and<br>curing unit make up the<br>system. | Same with wording<br>differences |
| Attribute | Proposed Device<br>DMG Digital Enterprises<br>SE LuxaPrint Ortho Plus<br>(current submission) | Predicate Device<br>EnvisionTEC GmbH<br>E-Guard<br>(K201173) | Similarities and<br>Differences |
| Use<br>Environment | Dental office/clinic, dental<br>laboratory for appliance<br>design and fabrication;<br>home use for the resulting<br>dental appliance. | Dental office/clinic, dental<br>laboratory for appliance<br>design and fabrication;<br>home use for the resulting<br>dental appliance. | Same |
| Material<br>Composition | Photocurable (meth)-<br>acrylate-based polymer<br>resin | Photocurable (meth)-<br>acrylate-based polymer<br>resin | Same |
| Principle of<br>Operation | The device consists of raw<br>material that is used to<br>fabricate removable custom<br>dental appliances, such as<br>orthodontic splints and/or<br>mouthguards. The finished<br>devices can be used to<br>support tooth stabilization<br>following active<br>orthodontic treatment,<br>and/or for the relief of<br>bruxism or snoring. The<br>device is used in<br>conjunction with a<br>compatible scanner, 3D<br>printer, and curing unit. | The device consists of raw<br>material that is used to<br>fabricate removable<br>custom dental appliances,<br>such as orthodontic splints<br>and/or mouthguards. The<br>finished devices can be<br>used to support tooth<br>stabilization following<br>active orthodontic<br>treatment, and/or for the<br>relief of bruxism or<br>snoring. The device is<br>used in conjunction with a<br>compatible scanner, 3D<br>printer, and curing unit. | Same |
| Water Solubility | 1.5 – 3.6 $ µg/mm³ $ (385 nm)<br>0.7 - 2.1 $ µg/mm³ $ (405 nm) | 0.5 $ µm/mm³ $ | Equivalent; both<br>meet ISO 4049 &<br>ISO 20795-2<br>requirements |
| Water Sorption | 18.6 – 20.3 (385 nm)<br>17.1 – 17.7 $ µg/mm³ $ (405<br>nm) | 37 $ µm/mm³ $ | Equivalent; both<br>meet ISO 4049 &<br>ISO 20795-2<br>requirements |
| Flexural<br>Strength | 80 – 93 MPa (385 nm)<br>77 - 90 MPa (405 nm) | 79 – 85 MPa | Equivalent; both<br>meet ISO 4049 &<br>ISO 20795-2<br>requirements |
| Flexural<br>Modulus | 1.9 - 2.4 GPa (385 nm)<br>2.1 - 2.5 GPa (405 nm) | 2052 - 2130 MPa | Equivalent; both<br>meet ISO 4049 &<br>ISO 20795-2<br>requirements |
| | Proposed Device | Predicate Device | Similarities and |
| Attribute | DMG Digital Enterprises<br>SE LuxaPrint Ortho Plus | EnvisionTEC GmbH<br>E-Guard | Differences |
| | (current submission) | (K201173) | |
| Biocompatibility | ISO 10993 | ISO 10993-1<br>Biocompatibility<br>Assessment<br>ISO 10993-5 Cytotoxicity<br>ISO 10993-10 Irritation<br>ISO 10993-10<br>Sensitization<br>ISO 10993-3 Genotoxicity | Equivalent |
| Single Use /<br>Reusable | Single Use | Single Use | Same |
| Sterilization /<br>Reprocessing | Non-sterile device; no<br>reprocessing requirements | Non-sterile device; no<br>reprocessing requirements | Same |
| Software | Device does not contain<br>software | Device does not contain<br>software | Same |
| Electrical Safety<br>& EMC | Not applicable | Not applicable | Same |
| Compatible 3D<br>Printer Type | DLP / SLA operating at 385<br>nm or 405 nm | DLP / SLA operating at 385<br>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

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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.