(60 days)
Not Found
No
The 510(k) summary describes a 3D printable resin for dental appliances and a standard 3D printing workflow. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a resin used for the fabrication of "orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners," which are explicitly stated to be for therapeutic purposes.
No
Explanation: The device is described as a light-cured resin for the fabrication of orthodontic and dental appliances, not for diagnosing conditions. Its use is based on a professional's diagnosis and prescription, meaning it is a therapeutic or restorative device.
No
The device is a light-cured resin for 3D printing dental appliances, which is a physical material, not software.
Based on the provided information, the Glidewell TuffSplint™ Appliance Resin is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Glidewell TuffSplint™ Appliance Resin is a material used to fabricate custom-fitted dental appliances (bite planes, mouthguards, etc.). These appliances are placed in the patient's mouth and interact with their oral anatomy.
- Lack of Diagnostic Purpose: The resin itself and the resulting appliance are not used to diagnose any disease or condition by analyzing a sample from the body. Their purpose is therapeutic or protective (e.g., preventing teeth grinding, repositioning the jaw).
The information provided clearly describes a material used for manufacturing a medical device that is applied in vivo (within the living body), not a test performed in vitro (outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Glidewell TuffSplint™ Appliance Resin is indication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
Device Description
Glidewell TuffSplint™ Appliance Resin is a light-cured resin for the fabrication of orthodontic and dental appliances. The resin can be used in DLP printers utilizing a wavelength of 385nm. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription. Glidewell TuffSplint™ Appliance Resin, in its final fabricated form, is a removable appliance that is fitted to a patient's oral anatomy and is maintained by the patient. The mechanism of a patient fitting starts with creating an impression of the patient's teeth via traditional or digital techniques, and then transferring that impression into a finished appliance via a validated 3D printing workflow.
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
Not Found
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 data submitted to demonstrate substantial equivalence include:
- Flexural strength and flexural modulus, according to ISO 20795-2:2013
- Water sorption and water solubility, according to ISO 20795-2:2013
- Tensile Strength, Tensile Modulus and Elongation, according to ASTM D638-14
- Packaging validation
- Biocompatibility
No clinical data is included in this submission.
Printing Accuracy and Printing Orientation Validation: A printing accuracy test was performed to validate that the physical output of the additive manufacturing system and procedure for Glidewell TuffSplint™ Appliance Resin is able to meet design input dimensions within the pre-specified tolerance. A printing orientation test was performed to validate that the hard resin printed at different print direction within the build space relative to the device orientation and at different build plate locations can meet the same performance criteria. The results met the pre-specified acceptance criteria and demonstrated that the subject device, Glidewell TuffSplint™ Appliance Resin, can be reliably fabricated at different print directions within the build space and at different build plate locations using the additive manufacturing system and procedure.
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.
KeyPrint KeySplint Soft Resin (K183598)
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
February 17, 2023
Prismatik Dentalcraft, Inc. Jiahe Li Sr. Regulatory Specialist 2144 Michelson Drive Irvine, California 92612
Re: K223798
Trade/Device Name: Glidewell TuffSplint™ Appliance Resin Regulatory Class: Unclassified Product Code: MQC, KMY Dated: December 15, 2022 Received: December 19, 2022
Dear Jiahe Li:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223798
Device Name Glidewell TuffSplint™ Appliance Resin
Indications for Use (Describe)
Glidewell TuffSplint™ Appliance Resin is indication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, 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)
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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangular shape with a color wheel design. To the right of the shape is the company name, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. The text is in a blue sans-serif font.
K223798
510(k) Summary
I. SUBMITTER
Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA Primary Contact Person: Jiahe Li, Sr. Regulatory Affairs Specialist Email: Jiahe.Li@glidewelldental.com Phone: (949) 222-3516 Secondary Contact Person: Maria Wagner, Sr. RA Manager Email: Maria.Wagner@glidewelldental.com Phone: (949) 838-1321 Date Prepared: December 15, 2022
DEVICE II.
Name of Device: Glidewell TuffSplint™ Appliance Resin Classification Product Code: MQC Regulatory Class: Unclassified Common Name: Mouthguard, Prescription; Classification Name: N/A, Pre-Amendment Subsequent Product Code: KMY Regulatory Class: Class I Common Name: Positioner, Tooth, Preformed Classification Name: Preformed tooth positioner
PRIMARY PREDICATE III.
KeyPrint KeySplint Soft Resin (K183598)
DEVICE DESCRIPTION IV.
Glidewell TuffSplint™ Appliance Resin is a light-cured resin for the fabrication of orthodontic and dental appliances. The resin can be used in DLP printers utilizing a wavelength of 385nm. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription. Glidewell TuffSplint™ Appliance Resin, in its final fabricated form, is a removable appliance that is fitted to a patient's oral anatomy and is maintained by the patient. The mechanism of a patient fitting starts with creating an impression of the patient's teeth via traditional or digital techniques, and then transferring that impression into a finished appliance via a validated 3D printing workflow.
INDICATIONS FOR USE V.
Prismatik Dentalcraft. Inc. 510(k) Notification Glidewell TuffSplint™ Appliance Resin December 2022
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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side that is divided into sections of different colors, including pink, blue, and yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a blue sans-serif font. The text is arranged in two lines, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
Glidewell TuffSplint™ Appliance Resin is indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
| Technological
Characteristics | | Subject Device
Glidewell TuffSplint™
Appliance Resin | Predicate Device
KeyPrint KeySplint Soft
Resin (K183598) | Comparison |
|-------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design
Characteristics | Manufacturer | Prismatik Dentalcraft, Inc. | Keystone Industries | N/A |
| | Product Code | MQC, KMY | MQC, KMY | Same |
| | Prescription Device | Yes | Yes | Same |
| Intended Use | | Resin for orthodontic and
dental appliances | Resin for orthodontic
and dental appliances | Same |
| Indications for Use | | Glidewell TuffSplint™
Appliance Resin is
indicated for the
fabrication of orthodontic
and dental appliances such
as bite planes,
mouthguards, nightguards,
splints and repositioners. | The KeyPrint KeySplint
Soft device is indicated
for the fabrication of
orthodontic and dental
appliances such as bite
planes, mouthguards,
nightguards, splints and
repositioners. | The indications for use
are the same except for
the device trade name. |
| General Design | | Light-cured resin using
3D printing technology to
convert the liquid resin to
solid orthodontic and
dental appliances. | Light-cured resin using
3D printing technology
to convert the liquid
resin to solid orthodontic
and dental appliances. | Same |
| Material
composition | | Light cured methacrylate
based-resin. | Light cured methacrylate
based-resin. | Substantially
equivalent |
| Additive
Manufacturing
System | | Glidewell TuffSplint™
Appliance Resin is
intended to be used in
conjunction with an
additive Computer- Aided
Manufacturing (CAM)
and curing system. | The KeyPrint KeySplint
Soft device is intended to
be used in conjunction
with an additive
Computer- Aided
Manufacturing (CAM)
and curing system. | Same |
| Technological
Characteristics | | Subject Device
Glidewell TuffSplint™
Appliance Resin | Predicate Device
KeyPrint KeySplint Soft
Resin (K183598) | Comparison |
| | Bench Testing
(physical
property) | Physical properties
according to
• ISO 20795-2:
Flexural Strength,
Flexural Modulus,
Water
Sorption/Solubility
• ASTM D638:
Tensile Strength,
Tensile Modulus,
Elongation | Physical properties
according to
• ASTM D790:
Flexural Properties
• ISO 20795-2:
Flexural Strength,
Flexural Modulus,
Water
Sorption/Solubility
• ASTM D638:
Tensile Strength,
Tensile Modulus,
Elongation | The predicate device
was tested for flexural
properties according to
ASTM D790 in
addition to ISO 20795-
2. The difference has
no impact on the
substantial equivalence
determination. |
| | Biocompatibility | Biocompatible per testing
results according to ISO
10993-1 | Biocompatible per
testing results according
to ISO 10993-1 | Same |
| | Sterility | Non-Sterile | Non-Sterile | Same |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a triangular prism on the left side, with the colors of the rainbow fanning out from the center. To the right of the prism, the text "PRISMATIK" is stacked on top of "DENTALCRAFT, INC." The text is in a sans-serif font and is colored blue.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The subject device. Glidewell TuffSplint™ Appliance Resin, is substantially equivalent to the primary predicate device, KeyPrint KeySplint Soft Resin (K183598) in intended use, indications for use and technological characteristics, including technical specifications/features, material and principles of operation.
The subject device, Glidewell TuffSplint™ Appliance Resin, has the same intended use as the predicate device, KeyPrint KeySplint Soft Resin (K183598) as material for fabricating prescription mouthguards and preformed tooth positioners. The subject device, Glidewell TuffSplint™ Appliance Resin, has the same Indications for Use Statement (IFUS) as the predicate device, KeyPrint KeySplint Soft Resin (K183598), except for the device trade name. Both the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are dental resin indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
The subject device, Glidewell TuffSplint™ Appliance Resin, is substantially equivalent to the predicate device, KeyPrint KeySplint Soft Resin (K183598) in technical specifications/features. The product specifications of the subject device, Glidewell TuffSplint™ Appliance Resin, is based on benchmarking comparable
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
devices with similar indications for use on the market, including the predicate device, KeyPrint KeySplint Soft Resin (K183598). The same property testing according to ISO 20795-2:2013 and ASTM D638-14 that applied to the predicate device, KeyPrint KeySplint Soft Resin (K183598), were performed on the subject device, Glidewell TuffSplint™ Appliance Resin, including flexural strength, flexural modulus, water sorption, water solubility, tensile strength, tensile modulus and elongation. The physical property of the subject device, Glidewell TuffSplint™ Appliance Resin, passed the threshold of performance criteria in ISO 20795-2:2013 when applicable to the design, and met the same performance criteria used by the predicate device, KeyPrint KeySplint Soft Resin (K183598).
The subject device, Glidewell TuffSplint™ Appliance Resin and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are similar in material composition. Both the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are light cured methacrylate-based resin. Despite the actual difference that might exist between the formulations, the difference does not affect the safety and effectiveness for the indended use, as verified by the safety and performance testing.
The subject device, Glidewell TuffSplint™ Appliance Resin, is substantially equivalent to the predicate device, KeyPrint KeySplint Soft Resin (K183598) in terms of principle of operation. Both the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are lightcured resin in liquid form that through light-mediated conversion can be fabricated into a solid finished device. The finished device has the desired physical properties suitable for orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
VII. PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence include:
- Flexural strength and flexural modulus, according to ISO 20795-2:2013 ●
- Water sorption and water solubility, according to ISO 20795-2:2013 ●
- Tensile Strength, Tensile Modulus and Elongation, according to ASTM D638-● 14
- Packaging validation ●
- Biocompatibility
No clinical data is included in this submission.
Flexural Strength and Flexural Modulus
The subject device, Glidewell TuffSplint™ Appliance Resin, was tested for flexural strength and flexural modulus in accordance to the test methods outlined in ISO 20795-2:2013. All the testing results met the acceptance criteria. The results of the testing were used to address questions related to substantial equivalence based on
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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular shape on the left, followed by the company name in blue text on the right. The word "PRISMATIK" is on the top line, and "DENTALCRAFT, INC." is on the bottom line.
differences in technical specifications between the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
Water Sorption and Water Solubility
The subject device. Glidewell TuffSplint™ Appliance Resin, was tested for water sorption and water solubility in accordance to ISO 20795-2:2013. All the testing results met the acceptance criteria. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device. Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
Tensile Strength, Tensile Modulus and Elongation
The subject device, Glidewell TuffSplint™ Appliance Resin, was tested for tensile strength, tensile modulus and elongation in accordance to ASTM D638-14. All the testing results met the acceptance criteria. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
Printing Accuracy and Printing Orientation Validation
A printing accuracy test was performed to validate that the physical output of the additive manufacturing system and procedure for Glidewell TuffSplint™ Appliance Resin is able to meet design input dimensions within the pre-specified tolerance. A printing orientation test was performed to validate that the hard resin printed at different print direction within the build space relative to the device orientation and at different build plate locations can meet the same performance criteria. The results met the pre-specified acceptance criteria and demonstrated that the subject device, Glidewell TuffSplint™ Appliance Resin, can be reliably fabricated at different print directions within the build space and at different build plate locations using the additive manufacturing system and procedure.
Packaging Validation
Packaging validation tests were performed for the subject device. Glidewell TuffSplint™ Appliance Resin. Per ASTM D4169-16, the shipping unit was tested for manual handling, compressive loads, repetitive shocks from vibration, low pressure hazard environment, vehicle & air transport vibration, concentrated impacts and secondary manual handling drops. In addition, the integrity of the packaging was tested on heated environment (55°C) under the ullage test. It was determined that Glidewell TuffSplint™ Appliance Resin with the respective packaging, is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
Biocompatibility
The subject device, Glidewell TuffSplint™ Appliance Resin, was tested in accordance with ISO 10993-1:2018. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device. The results of the testing were used to address questions related to substantial equivalence based on differences in chemical composition between the subject device, Glidewell TuffSplint™ Appliance Resin, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
VIII. CONCLUSION
Based on technological characteristics and non-clinical test data included in this submission, the subject device, Glidewell TuffSplint™ Appliance Resin, has been shown to be substantially equivalent to the predicate device. KeyPrint KeySplint Soft Resin (K183598).