Who is the manufacturer of Glidewell TuffSplint Appliance Resin?

Prismatik Dentalcraft, Inc. filed the 510(k) submission for Glidewell TuffSplint Appliance Resin (K223798).

What is the FDA product code for Glidewell TuffSplint Appliance Resin?

MQC. as a Class U device in the DE panel.

What is the regulatory pathway for Glidewell TuffSplint Appliance Resin?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Glidewell TuffSplint Appliance Resin?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Glidewell TuffSplint Appliance Resin

K223798 · Prismatik Dentalcraft, Inc. · MQC · Feb 17, 2023 · DE

Device Facts

Record ID	K223798
Device Name	Glidewell TuffSplint Appliance Resin
Applicant	Prismatik Dentalcraft, Inc.
Product Code	MQC · DE
Decision Date	Feb 17, 2023
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Glidewell TuffSplint™ Appliance Resin is indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.

Device Story

Glidewell TuffSplint™ Appliance Resin is a light-cured, methacrylate-based resin used for 3D printing custom orthodontic and dental appliances; compatible with DLP printers (385nm wavelength). Workflow involves creating patient dental impressions via traditional or digital methods, followed by a validated 3D printing process to fabricate the final appliance. The device is intended for prescription use; the finished appliance is removable and patient-maintained. It serves as a material for bite planes, mouthguards, nightguards, splints, and repositioners. Clinical benefit is derived from providing custom-fitted oral appliances tailored to patient anatomy, supporting dental professional diagnosis and treatment plans.

Clinical Evidence

No clinical data. Evidence is based on bench testing: flexural strength/modulus (ISO 20795-2:2013), water sorption/solubility (ISO 20795-2:2013), tensile strength/modulus/elongation (ASTM D638-14), printing accuracy/orientation validation, packaging validation (ASTM D4169-16), and biocompatibility (ISO 10993-1:2018).

Technological Characteristics

Light-cured methacrylate-based resin; 3D printing (DLP, 385nm); non-sterile. Physical properties tested per ISO 20795-2:2013 and ASTM D638-14. Biocompatible per ISO 10993-1:2018. Intended for use with additive CAM and curing systems.

Indications for Use

Indicated for the fabrication of orthodontic and dental appliances including bite planes, mouthguards, nightguards, splints, and repositioners for patients requiring such devices.

Predicate Devices

KeyPrint KeySplint Soft Resin (K183598)

Related Devices

K253798 — UltraPrint-Dental Hard Splint UV · Guangzhou Heygears IMC., Inc. · Mar 2, 2026
K214102 — Glidewell Appliance Resin, Hard/Soft · Prismatik Dentalcraft, Inc. · Feb 23, 2022
K232448 — FREEPRINT® splintmaster · Detax GmbH · Oct 12, 2023
K232087 — Dental LT Comfort Resin · Formlabs Ohio, Inc. · Feb 16, 2024
K241729 — Hard Splint & Thermo-Adaptive Splint · Whip Mix Corporation · Mar 18, 2025

Submission Summary (Full Text)

{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) ### 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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). {8}------------------------------------------------ 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).