(59 days)
FREEPRINT® splintmaster is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT® splintmaster is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.
The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce dental mouthguards, nightguards, splints, and repositioners. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment.
The Subject device is used by a dental professional (dentist or dental technician) for the additive Computer-Aided Manufacturing (CAM) of dental mouthguards, nightguards, splints, and repositioners. There are two models of the Subject device which are referred to as FREEPRINT® splintmaster flex and FREEPRINT® splintmaster taff with slightly different material properties for either a more flexible or rigid final product.
The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.
The provided text describes a 510(k) premarket notification for a medical device called FREEPRINT® splintmaster. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving the device meets them.
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses:
- Indications for Use: What the device is intended for (fabrication of orthodontic and dental objects like mouthguards, splints, and repositioners).
- Device Description: It's a light-cured methacrylate-based resin used in 3D printers.
- Equivalence to Marketed Devices: Comparison of the subject device with predicate devices (GR Splint Resin System, KeyPrint KeySplint Soft, KeyPrint KeySplint Hard) in terms of indications for use and technological characteristics.
- Non-Clinical Performance Testing: Mentions that physical property testing was performed to ISO 20795-2, and biocompatibility testing was done to ISO 10993 standards. It also states that "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above."
Missing Information:
Crucially, the document explicitly states:
- "No clinical or animal testing data is included in this submission."
- It does not provide a table of acceptance criteria, specific performance numbers for the device against those criteria, or details regarding the methodologies for setting ground truth, expert qualifications, sample sizes for test or training sets, MRMC studies, or standalone performance.
**Therefore, I cannot fulfill your request for: **
- A table of acceptance criteria and the reported device performance: This detailed information is not present. The document only broadly states that the device met acceptance criteria for non-clinical tests.
- Sample sizes used for the test set and the data provenance: Not specified, as clinical data was not included. "Test set" here refers to non-clinical chemical and mechanical tests, not a clinical dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as ground truth typically refers to clinical diagnosis or outcomes, which were not part of this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical material testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Explicitly stated "No clinical or animal testing data is included."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a material (resin) for dental manufacturing, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it's not a diagnostic device or AI. The "ground truth" for the material is its physical and chemical properties as measured by ISO standards.
- The sample size for the training set: Not applicable, as no AI model was described requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document is a clearance letter for a 3D printing resin based on engineering and material property testing, rather than an AI/diagnostic device that would typically involve the detailed study information you are asking for.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2023
Detax GmbH % Chris Brown Manager Aclivi, LLC 3250 Brackley Drive Ann Arbor, Michigan 48105
Re: K232448
Trade/Device Name: FREEPRINT® splintmaster Regulatory Class: Unclassified Product Code: MQC, KMY Dated: August 11, 2023 Received: August 14, 2023
Dear Chris Brown:
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 (the 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 available 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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
{2}------------------------------------------------
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name FREEPRINT® splintmaster
Indications for Use (Describe)
FREEPRINT® splintmaster is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT® splintmaster is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.
| 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) |
|X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary K232448 DETAX GmbH FREEPRINT® splintmaster 10/11/2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | DETAX GmbHCarl-Zeiss-Strasse 4D-76275 Ettingen, GermanyTelephone: +49 7243/510-138 | Consultant: | Aclivi, LLC3250 Brackley DriveAnn Arbor, Michigan 48105Telephone: +1 810 360-9773 |
|---|---|---|---|
| Official Contact:Email: | Markus Stratmann - Divisional Director 3DMarkus.Stratmann@detax.de | Chris Brown - Manageracliviconsulting@gmail.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | FREEPRINT® splintmaster |
|---|---|
| Common Name: | Mouthguard, Prescription |
| Regulation Name/Number: | Unclassified |
| Device Class: | Unclassified |
| Product Code: | MQC, KMY |
| Review Panel: | Dental |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device.
| 510(k) | Primary Predicate Device Name | Company Name |
|---|---|---|
| K211415 | GR Splint Resin System | Pro3dure Medical GmbH |
| 510(k) | Secondary Predicate Device Name | Company Name |
| K183598 | KeyPrint KeySplint Soft | Keystone Industries |
Keystone Industries
INDICATIONS FOR USE
FREEPRINT® splintmaster is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT® splintmaster is indication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.
KeyPrint KeySplint Hard
DEVICE DESCRIPTION
The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce dental mouthguards, nightguards, splints, and repositioners. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment.
The Subject device is used by a dental professional (dentist or dental technician) for the additive Computer-Aided Manufacturing (CAM) of dental mouthguards, nightguards, splints, and repositioners. There are two models of
{5}------------------------------------------------
the Subject device which are referred to as FREEPRINT® splintmaster flex and FREEPRINT® splintmaster taff with slightly different material properties for either a more flexible or rigid final product.
The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.
Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.
EQUIVALENCE TO MARKETED DEVICE
The Subject device is highly similar to the Predicate devices with respect to Indications for Use and technological principles. The comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate devices.
| Device | Indications for Use Statement |
|---|---|
| Subject DeviceFREEPRINT® splintmasterDETAX GmbH | FREEPRINT® splintmaster is a light-curable polymerizable resin intended to be used in conjunctionwith extra-oral curing light equipment. FREEPRINT® splintmaster is indicated for the fabrication, byadditive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards,splints, and repositioners. |
| Primary Predicate DeviceGR Splint Resin System (K211415)Pro3dure Medical GmbH | The GR Splint Resin System is a light-curable polymerizable resin intended to be used in conjunctionwith extra-oral curing light equipment:The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic anddental objects such as splints. |
| The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dentalobjects such as mouthguards, nightguards, splints, repositioners and retainers.The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic anddental objects such as mouthguards, nightguards, splints, and repositioners. | |
| Secondary Predicate DeviceKeyPrint KeySplint Soft (K183598)Keystone Industries | The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dentalappliances such as mouthguards, nightguards, splints and repositioners. |
| Secondary Predicate DeviceKeyPrint KeySplint Hard (K203000)Keystone Industries | The KeyPrint" KeySplint Hard™ device is indicated for the fabrication of orthodontic anddental appliances such as mouthguards, nightguards, splints, repositioners and retainers. |
Indications For Use
The Subject and Predicate Indications for Use Statements (IFUS) are highly similar differing in the specific device names, specifically with respect to the GR-22 flex model which shares the same intended use as the Subject device. The Secondary Predicate device IFUS are also similar in wording, differing in device names but lacking the specific reference to being used in conjunction with extra-oral curing equipment even though extra-oral curing equipment is used to cure these devices. The slight differences in the wording within Indications for Use Statements does not change the intended use of the Subject and Predicate orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.
{6}------------------------------------------------
Technological Characteristics
| Parameter | Subject Device | Primary Predicate Device | Secondary Predicate Device | Secondary Predicate Device |
|---|---|---|---|---|
| FREEPRINT® splintmasterDETAX GmbH | GR Splint Resin System (K211415)Pro3dure Medical GmbH | KeyPrint KeySplint Soft (K183598)Keystone Industries | KeyPrint KeySplint Hard (K203000)Keystone Industries | |
| Reason for Predicate | n/a | IFUS, Technological Characteristics,Comparative Bench Performance Testing | Comparative Bench PerformanceTesting | Comparative Bench PerformanceTesting |
| Product Code | MQC, KMY | MQC, EBI, KMY | MQC, KMY | MQC, KMY, EBI |
| Device | Mouthguard, Prescription | Mouthguard, Prescription | Mouthguard, Prescription | Mouthguard, Prescription |
| Regulatory Class | Unclassified | Unclassified | Unclassified | Unclassified |
| Intended Use | A light-cured methacrylate-based resinused in conjunction with 3D printers(additive manufacturing) and curingsystems to produce mouthguards,nightguards, splints, and repositioners. | A light-cured methacrylate-based resinused in conjunction with additiveComputer-Aided Manufacturing (CAM) andcuring systems to produce mouthguards,nightguards, splints, and repositioners. | A UV light-cured methacrylate-based resin used for the 3D printingof various dental devices such asmouthguards, nightguards, splints,and repositioners. | A UV light-cured methacrylate-based resin used for the 3D printingof various dental devices such asmouthguards, nightguards, splints,and repositioners. |
| Technology | 3D liquid (light-cured) print resin for dentalCAD/CAM | 3D liquid (light-cured) print resin for dentalCAD/CAM | 3D liquid (light-cured) print resin fordental CAD/CAM | 3D liquid (light-cured) print resin fordental CAD/CAM |
| Biocompatible | Yes | Yes | Yes | Yes |
| OTC or Rx | Rx | Rx | Rx | Rx |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Chemical Composition | Methacrylate resin, photo initiator | Methacrylate monomer resin, photoinitiator | Methacrylate monomer resin,photo initiator | Methacrylate monomer resin,photo initiator |
| Polymerization (Curing) Method | UV light, 385 nmw/post curing | UV light, 385-405 nmw/post curing | UV light, 385-405 nmw/post curing | UV light, 385-405 nmw/post curing |
| Equipment | Validated 3D-Printer and post curingdevices | Validated 3D-Printer and post curingdevices | Validated 3D-Printer and postcuring devices | Validated 3D-Printer and postcuring devices |
| Performance Testing | ISO 20795-2 | ISO 20795-2ASTM D256ISO 37 | ISO 20795-2ASTM D256ISO 37 | ISO 20795-2ASTM D256ISO 37 |
| Biocompatibility Testing | ISO 7405ISO 10993-1ISO 10993-3ISO 10993-5ISO 10993-10ISO 10993-11ISO 10993-17ISO 10993-18ISO 10993-23ISO/TS 21726 | ISO 10993Specific standards not listed in 510(k)Summary document. | ISO 10993Specific standards not listed in510(k) Summary document. | ISO 10993Specific standards not listed in510(k) Summary document. |
Product Code/Device/Classification - The Subject and Predicate devices share highly similar designations. The lack of the secondary EBI Product Code does not impact or change the intended use of the Subject device.
Intended Use - The Subject and Predicate devices are Highly Similar in their intended use, effectively conveying the same intended use with slight differences in wording.
Biocompatible/Rx/Sterility - The Subject and Predicate devices share the same designations.
Chemical Composition - The Subject and Predicate devices are the same in they are both UV-light cured liquid methacrylate-based resins with photo initiator(s). Slight differences in chemical composition do not change the intended use of the Subject and Predicate devices to be used in the fabrication of dental mouthguards, nightguards, splints, and repositioners. The Subject device has demonstrated suitability for intended use through material non-clinical performance testing.
Polymerization (Curing) Method/Equipment - The Subject and Predicate devices are the same in that they are both light-cured polymer resins encompassing the same range of curing wavelengths and used with validated 3D printer/post-curing workflows. Any differences in the curing light wavelength does not change the intended use of the Subject and Predicate devices to be used in the fabrication of the intended dental devices.
Performance Testing – The Subject and Predicate devices were tested by their respective sponsors to the same ISO 20795-2 material property standard, meeting most of the standard. Comparative testing was performed with the Subject and Predicate devices to ISO 20795-2, ISO 527-1 and ISO 179-1 which demonstrated similar performance for the ISO 20795-2 properties as well as tensile strength, elongation at break and Charpy Impact.
{7}------------------------------------------------
Biocompatibility - The Subject and Predicate devices are similar in the standards and biological endpoints the devices were evaluated to. Slight differences in the standards and tested endpoints do not change the intended use of the Subject and Predicate devices.
Overall, the Technological Characteristics of the Subject and Predicate devices are the Same or Highly Similar. Technological differences between the Subject and Predicate devices have been evaluated through non-clinical performance testing. The results of the tests performed show that Subject device meets the requirements mentioned in the applicable standards and confirm that the Subject device performs similarly to the Predicate devices.
CLINICAL AND ANIMAL TESTING
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission.
NON-CLINICAL PERFORMANCE TESTING
Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input.
Physical property testing was performed on the Subject device to ISO 20795-2, Dentistry — Part 2: Orthodontic base polymers. Performance testing on the Subject device was performed for the surface finish, shape capability, color, freedom from porosity, flexural modulus, maximum stress intensity factor, total work fracture, water sorption, water solubility endpoints identified in ISO 20795-2. Comparative material property testing was also performed with the Predicate devices to these endpoints demonstrating similar performance.
A biological evaluation was performed on the Subject device. Chemical characterization was performed to ISO 10993-18 with a risk assessment performed according to ISO 10993-17 and ISO/TS 21726. Biocompatibility testing was performed on the Subject device according to ISO 10993-1:2018 and ISO 7405:2014 according to the standards listed in the Technological Characteristics comparison table above.
An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.
CONCLUSION
Overall, the Indications for Use statements for the Subject and Predicate devices are highly similar differing only in device name and slightly in use duration. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Predicate device with any differences mitigated through nonclinical performance testing.
Overall, these similarities between the Subject and Predicate devices, support a determination of substantial equivalence.
N/A