(158 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for a dental material (LuxaPrint Ortho Plus), not an AI/ML medical device. Therefore, the information typically required to answer questions about acceptance criteria and studies proving an AI/ML device meets them (such as validation of an algorithm's performance, human-in-the-loop studies, details of training/test sets, expert adjudication methods, etc.) is not present in this document.
The document discusses the substantial equivalence of the LuxaPrint Ortho Plus (a photocurable polymer resin for 3D printing dental appliances) to a predicate device (EnvisionTEC GmbH E-Guard). The "acceptance criteria" here refer to the physical and chemical properties of the material, not the performance of an AI algorithm.
However, I can extract the information related to the material's acceptance criteria and the non-clinical performance testing detailed in the document, even though it doesn't align with the typical AI/ML device validation questions.
Here's a breakdown based on the provided text, interpreting the questions in the context of a dental material if direct AI/ML answers aren't available:
Acceptance Criteria and Study for LuxaPrint Ortho Plus (Dental Material)
1. Table of Acceptance Criteria and Reported Device Performance
For this dental material, the "acceptance criteria" are based on physical and chemical properties, often aligning with ISO standards for dental materials. The study proves that the material meets these properties, demonstrating its comparability to the predicate device.
| Attribute | Acceptance Criteria (Predicate Device K201173) | Reported Device Performance (LuxaPrint Ortho Plus) | Similarity/Difference & Compliance |
|---|---|---|---|
| Water Solubility | 0.5 µg/mm³ | 1.5 – 3.6 µg/mm³ (385 nm) 0.7 - 2.1 µg/mm³ (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements |
| Water Sorption | 37 µg/mm³ | 18.6 – 20.3 µg/mm³ (385 nm) 17.1 – 17.7 µg/mm³ (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements |
| Flexural Strength | 79 – 85 MPa | 80 – 93 MPa (385 nm) 77 - 90 MPa (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements |
| Flexural Modulus | 2052 - 2130 MPa | 1.9 - 2.4 GPa (385 nm) 2.1 - 2.5 GPa (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements (Note: GPa vs MPa, 1 GPa = 1000 MPa, so values are comparable). |
| Biocompatibility | ISO 10993-1, -5, -10, -3 | ISO 10993 | Equivalent (LuxaPrint Ortho Plus tested under ISO 10993, implicitly meeting relevant parts). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Performance data demonstrated that finished devices manufactured using the LuxaPrint Ortho Plus material meet all predetermined acceptance criteria..." and "3D printed devices fabricated using LuxaPrint Ortho Plus have been tested for and found to have comparable physical properties..." However, specific numerical sample sizes for each test (e.g., how many specimens for flexural strength) are not provided in this summary.
- Data Provenance: The tests were "Non-clinical Performance Testing." The "Owner's Name" and address for DMG Dental Enterprises SE is Hamburg, Germany. This suggests the testing likely occurred in Germany or under the oversight of the German manufacturer. The document doesn't specify if the testing was retrospective or prospective in the sense of a clinical trial; these are physical material property tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this dental material submission. "Ground truth" for an AI/ML device typically refers to expert-labeled data for an algorithm's output. For a physical material like LuxaPrint Ortho Plus, the "ground truth" is established by direct physical and chemical measurements (e.g., using calibrated lab equipment) and adherence to international standards (ISO). No human experts are used to "label" or "adjudicate" the material's physical properties.
4. Adjudication Method for the Test Set
This question is not applicable. No human adjudication is involved in determining the physical properties of a material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This question is not applicable. An MRMC study is relevant for evaluating the performance of medical imaging devices or AI algorithms that assist human readers. This submission is for a dental material with no reading component.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm or software component described for this device. The device itself is the material.
7. The Type of Ground Truth Used
For this dental material, the "ground truth" used for testing was based on:
- Standardized Physical and Chemical Measurements: This includes properties like water solubility, water sorption, flexural strength, and flexural modulus, measured according to established international standards (ISO 4049, ISO 20795-2).
- Biocompatibility Standards: Compliance with ISO 10993.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a physical resin material, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. See point 8.
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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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
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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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 24822547 HamburgGermany |
| 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 regulationEBI (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 regulationEBI (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
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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 DeviceDMG Digital EnterprisesSE LuxaPrint Ortho Plus(current submission) | Predicate DeviceEnvisionTEC GmbHE-Guard(K201173) | Similarities andDifferences |
|---|---|---|---|
| Common Name | Prescription Mouthguard | Prescription Mouthguard | Same |
| ClassificationName | Unclassified | Unclassified | Same |
| Device Class | Unclassified | Unclassified | Same |
| Regulation | N/A, 21 CFR 872.3760 | N/A, 21 CFR 872.3760 | Same |
| RegulationName | Mouthguard, PrescriptionResin, Denture, Relining,Repairing, Rebasing | Mouthguard, PrescriptionResin, Denture, Relining,Repairing, Rebasing | Same |
| Product Code | MQC, EBI | MQC, EBI | Same |
| Indicationsfor Use | Fabrication of orthodonticand dental appliances suchas mouthguards,nightguards, splints andpositioners. The product isfor use with DLP / SLAprinters that work atwavelengths of 385 nm or405 nm. | EnvisionTEC's E-Guard isa light-cured resin. It is apolymer used to createremovable structures fortherapeutic restorations,i.e., bite guards/splints andocclusal night guard/splintsusing the AdditiveManufacturing process.The resin in combinationwith a scanner, printer, andcuring unit make up thesystem. | Same with wordingdifferences |
| Attribute | Proposed DeviceDMG Digital EnterprisesSE LuxaPrint Ortho Plus(current submission) | Predicate DeviceEnvisionTEC GmbHE-Guard(K201173) | Similarities andDifferences |
| UseEnvironment | Dental office/clinic, dentallaboratory for appliancedesign and fabrication;home use for the resultingdental appliance. | Dental office/clinic, dentallaboratory for appliancedesign and fabrication;home use for the resultingdental appliance. | Same |
| MaterialComposition | Photocurable (meth)-acrylate-based polymerresin | Photocurable (meth)-acrylate-based polymerresin | Same |
| Principle ofOperation | The device consists of rawmaterial that is used tofabricate removable customdental appliances, such asorthodontic splints and/ormouthguards. The finisheddevices can be used tosupport tooth stabilizationfollowing activeorthodontic treatment,and/or for the relief ofbruxism or snoring. Thedevice is used inconjunction with acompatible scanner, 3Dprinter, and curing unit. | The device consists of rawmaterial that is used tofabricate removablecustom dental appliances,such as orthodontic splintsand/or mouthguards. Thefinished devices can beused to support toothstabilization followingactive orthodontictreatment, and/or for therelief of bruxism orsnoring. The device isused in conjunction with acompatible scanner, 3Dprinter, 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; bothmeet ISO 4049 &ISO 20795-2requirements |
| Water Sorption | 18.6 – 20.3 (385 nm)17.1 – 17.7 $ µg/mm³ $ (405nm) | 37 $ µm/mm³ $ | Equivalent; bothmeet ISO 4049 &ISO 20795-2requirements |
| FlexuralStrength | 80 – 93 MPa (385 nm)77 - 90 MPa (405 nm) | 79 – 85 MPa | Equivalent; bothmeet ISO 4049 &ISO 20795-2requirements |
| FlexuralModulus | 1.9 - 2.4 GPa (385 nm)2.1 - 2.5 GPa (405 nm) | 2052 - 2130 MPa | Equivalent; bothmeet ISO 4049 &ISO 20795-2requirements |
| Proposed Device | Predicate Device | Similarities and | |
| Attribute | DMG Digital EnterprisesSE LuxaPrint Ortho Plus | EnvisionTEC GmbHE-Guard | Differences |
| (current submission) | (K201173) | ||
| Biocompatibility | ISO 10993 | ISO 10993-1BiocompatibilityAssessmentISO 10993-5 CytotoxicityISO 10993-10 IrritationISO 10993-10SensitizationISO 10993-3 Genotoxicity | Equivalent |
| Single Use /Reusable | Single Use | Single Use | Same |
| Sterilization /Reprocessing | Non-sterile device; noreprocessing requirements | Non-sterile device; noreprocessing requirements | Same |
| Software | Device does not containsoftware | Device does not containsoftware | Same |
| Electrical Safety& EMC | Not applicable | Not applicable | Same |
| Compatible 3DPrinter Type | DLP / SLA operating at 385nm or 405 nm | DLP / SLA operating at 385nm | 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.
N/A