(59 days)
Not Found
No
The summary describes a light-curable resin used in 3D printing for dental devices. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties and manufacturing process.
Yes
The device is a resin used to fabricate medical devices like mouthguards, splints, and repositioners, which are used for therapeutic purposes such as supporting, correcting, or preventing physical conditions.
No
This device is a resin used to fabricate orthodontic and dental objects, not to diagnose a condition.
No
The device is a light-curable resin, which is a physical material used in 3D printing, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of orthodontic and dental objects like mouthguards, splints, and repositioners. These are devices that are placed in or on the body for therapeutic or protective purposes.
- Device Description: The device is a resin used in 3D printers to create these dental devices. It's a material used in a manufacturing process.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases, monitor conditions, or determine compatibility. This device's function is to create physical dental appliances.
N/A
Intended Use / 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 indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
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 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.
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 professional (dentist or dental technician)
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)
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.
Study Type: Validation of Manufacturing Process and Compatible Equipment
Summary: Performed to demonstrate consistency of the process output with that of the process input.
Study Type: Physical Property Testing to ISO 20795-2
Sample Size: Not specified
Summary: 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.
Study Type: Comparative Material Property Testing
Sample Size: Not specified
Summary: Performed with the Predicate devices to the ISO 20795-2 endpoints demonstrating similar performance. Comparative testing was performed 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.
Study Type: Biological Evaluation
Summary: 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.
Study Type: MRI Safety Assessment
Summary: 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".
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.
Not Found
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
N/A
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).
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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
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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)
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510(k) Summary K232448 DETAX GmbH FREEPRINT® splintmaster 10/11/2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | DETAX GmbH
Carl-Zeiss-Strasse 4
D-76275 Ettingen, Germany
Telephone: +49 7243/510-138 | Consultant: | Aclivi, LLC
3250 Brackley Drive
Ann Arbor, Michigan 48105
Telephone: +1 810 360-9773 |
|-----------------------------|------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------------------------------------|
| Official Contact:
Email: | Markus Stratmann - Divisional Director 3D
Markus.Stratmann@detax.de | | Chris Brown - Manager
acliviconsulting@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
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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 Device | |
| FREEPRINT® splintmaster | |
| DETAX GmbH | FREEPRINT® splintmaster is a light-curable polymerizable 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, nightguards, | |
| splints, and repositioners. | |
| Primary Predicate Device | |
| GR Splint Resin System (K211415) | |
| Pro3dure Medical GmbH | The GR Splint Resin System is a light-curable polymerizable resin intended to be used in conjunction |
| with extra-oral curing light equipment: | |
| The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and | |
| dental objects such as splints. | |
| The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental | |
| objects such as mouthguards, nightguards, splints, repositioners and retainers. | |
| The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and | |
| dental objects such as mouthguards, nightguards, splints, and repositioners. | |
| Secondary Predicate Device | |
| KeyPrint KeySplint Soft (K183598) | |
| Keystone Industries | The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental |
| appliances such as mouthguards, nightguards, splints and repositioners. | |
| Secondary Predicate Device | |
| KeyPrint KeySplint Hard (K203000) | |
| Keystone Industries | The KeyPrint" KeySplint Hard™ device is indicated for the fabrication of orthodontic and |
| dental 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.
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Technological Characteristics
| Parameter | Subject Device | Primary Predicate Device | Secondary Predicate Device | Secondary Predicate Device |
|---|---|---|---|---|
| FREEPRINT® splintmaster | ||||
| DETAX 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 Performance | |||
| Testing | Comparative Bench Performance | |||
| Testing | ||||
| 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 resin | |||
| used in conjunction with 3D printers | ||||
| (additive manufacturing) and curing | ||||
| systems to produce mouthguards, | ||||
| nightguards, splints, and repositioners. | A light-cured methacrylate-based resin | |||
| used in conjunction with additive | ||||
| Computer-Aided Manufacturing (CAM) and | ||||
| curing systems to produce mouthguards, | ||||
| nightguards, splints, and repositioners. | A UV light-cured methacrylate- | |||
| based resin used for the 3D printing | ||||
| of various dental devices such as | ||||
| mouthguards, nightguards, splints, | ||||
| and repositioners. | A UV light-cured methacrylate- | |||
| based resin used for the 3D printing | ||||
| of various dental devices such as | ||||
| mouthguards, nightguards, splints, | ||||
| and repositioners. | ||||
| Technology | 3D liquid (light-cured) print resin for dental | |||
| CAD/CAM | 3D liquid (light-cured) print resin for dental | |||
| CAD/CAM | 3D liquid (light-cured) print resin for | |||
| dental CAD/CAM | 3D liquid (light-cured) print resin for | |||
| dental 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, photo | ||
| initiator | Methacrylate monomer resin, | |||
| photo initiator | Methacrylate monomer resin, | |||
| photo initiator | ||||
| Polymerization (Curing) Method | UV light, 385 nm | |||
| w/post curing | UV light, 385-405 nm | |||
| w/post curing | UV light, 385-405 nm | |||
| w/post curing | UV light, 385-405 nm | |||
| w/post curing | ||||
| Equipment | Validated 3D-Printer and post curing | |||
| devices | Validated 3D-Printer and post curing | |||
| devices | Validated 3D-Printer and post | |||
| curing devices | Validated 3D-Printer and post | |||
| curing devices | ||||
| Performance Testing | ISO 20795-2 | ISO 20795-2 | ||
| ASTM D256 | ||||
| ISO 37 | ISO 20795-2 | |||
| ASTM D256 | ||||
| ISO 37 | ISO 20795-2 | |||
| ASTM D256 | ||||
| ISO 37 | ||||
| Biocompatibility Testing | ISO 7405 | |||
| ISO 10993-1 | ||||
| ISO 10993-3 | ||||
| ISO 10993-5 | ||||
| ISO 10993-10 | ||||
| ISO 10993-11 | ||||
| ISO 10993-17 | ||||
| ISO 10993-18 | ||||
| ISO 10993-23 | ||||
| ISO/TS 21726 | ISO 10993 | |||
| Specific standards not listed in 510(k) | ||||
| Summary document. | ISO 10993 | |||
| Specific standards not listed in | ||||
| 510(k) Summary document. | ISO 10993 | |||
| Specific standards not listed in | ||||
| 510(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.
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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.