Glidewell 3DP Denture Base Resin

{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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 22, 2022 Prismatik Dentalcraft, Inc. Jiahe Li Regulatory Affairs Specialist 2144 Michelson Drive Irvine, California 92612 Re: K213765 Trade/Device Name: Glidewell 3DP Denture Base Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: March 22, 2022 Received: March 24, 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/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. 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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 {1}------------------------------------------------ 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K213765 Device Name Glidewell™ 3DP Denture Base Resin ### Indications for Use (Describe) Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="10" y2="0"></line> </svg> </span> Prescription Use (Part 21 CER 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ Image /page/3/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 sections of different colors, including pink, red, yellow, green, blue, and purple. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. # K213765 510(k) Summary #### I. SUBMITTER Prismatik Dentalcraft, Inc. 2144 Michelson Drive. Irvine, CA 92612, USA Primary Contact Person: Jiahe Li, Regulatory Affairs Specialist Email: Jiahe.Li@glidewelldental.com Phone: (949) 222-3516 Secondary Contact Person: Herbert Crane, VP RA/QA Email: Herbert.Crane@glidewelldental.com Phone: (949) 222-3531 Date Prenared: November 30, 2021 #### DEVICE II. Name of Device: Glidewell™ 3DP Denture Base Resin Common Name or Usual Name: Denture Base Resin Classification Name: Denture relining, repairing, or rebasing resin (21 CFR 872.3760) Regulatory Class: Class II Product Code: EBI #### III. PRIMARY PREDICATE DEVICE GR-14 Resin System (K210298) #### IV. DEVICE DESCRIPTION Glidewell™ 3DP Denture Base Resin is a light-cured resin for the fabrication of removable 3DP denture bases, including full and partial dentures, fabricated in a professional dental setting. The resin is compatible with DLP printers utilizing wavelengths of 405nm and is offered in G1 (standard pink), G3 (medium pink) and G4 (dark pink) shades formulated to match gingival tissue. #### V. INDICATIONS FOR USE Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains 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 sections with different colors, including pink, blue, and yellow. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. | Technological<br>Characteristics | Subject Device<br>Glidewell™ 3DP Denture<br>Base Resin | Predicate Device<br>GR-14 Resin System<br>(K210298) | Comparison | | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Manufacturer | Prismatik Dentalcraft, Inc. | Pro3dure Medical GmbH | N/A | | | Product Code | EBI | EBI | Same | | | Prescription Device | Yes | Yes | Same | | | Intended Use | Denture base resin for partial<br>and full denture | Denture base resin for<br>partial and full denture | Same | | | Indications for Use | Glidewell™ 3DP Denture<br>Base Resin is a light-curable<br>polymerizable resin intended<br>to be used in conjunction<br>with extraoral curing light<br>equipment. Glidewell™ 3DP<br>Denture Base Resin is<br>indicated for the fabrication<br>and repair, by additive<br>manufacturing, of full and<br>partial removable dentures<br>and baseplates. | The GR-14.1 denture is a<br>light-curable<br>polymerizable resin<br>intended to be used in<br>conjunction with extraoral<br>curing light equipment.<br>The GR-14.1 denture is<br>indicated for the<br>fabrication and repair, by<br>additive manufacturing,<br>of full and partial<br>removable dentures and<br>baseplates.<br>The GR-14.2 denture HI<br>is a light-curable<br>polymerizable resin<br>intended to be used in<br>conjunction with extraoral<br>curing light equipment.<br>The GR-14.2 denture HI<br>is indicated for the<br>fabrication and repair, by<br>additive manufacturing,<br>of full and partial<br>removable dentures and<br>baseplates. | Only the trade names<br>are different between<br>the subject device,<br>Glidewell™ 3DP<br>Denture Base Resin,<br>and the predicate<br>device, GR-14 Resin<br>System (K210298).<br>The second part of the<br>Indications for Use<br>statement for the<br>predicate device, GR-<br>14 Resin System<br>(K210298) is the same<br>as the first part, except<br>for the change in the<br>trade name from GR-<br>14.1 to GR-14.2<br>denture HI. The<br>repeated part is not<br>included in the case of<br>the subject device,<br>Glidewell™ 3DP<br>Denture Base Resin.,<br>as it would be<br>redundant. | | | Technological<br>Characteristics | | Subject Device<br>GlidewellTM 3DP Denture<br>Base Resin | Predicate Device<br>GR-14 Resin System<br>(K210298) | Comparison | | Design<br>Characteristics | General Design | Light-cured denture base<br>resin using 3D printing<br>technology to convert the<br>liquid resin to solid dentures<br>and baseplates | Light-cured denture base<br>resin using 3D printing<br>technology to convert the<br>liquid resin to solid<br>dentures and baseplates | Same | | | Material<br>composition | Methacrylate/dimethacrylate-<br>based resins with photo-<br>initiator, stabilizer, filler and<br>pigments. | Methacrylate<br>/dimethacrylates, photo-<br>initiator, stabilizer, filler<br>and pigments. | Substantially<br>equivalent | | | Additive<br>Manufacturing<br>System | GlidewellTM 3DP Denture<br>Base Resin is intended to be<br>used in conjunction with an<br>additive Computer- Aided<br>Manufacturing (CAM) and<br>curing system such as<br>Nyomo, Rapidshape,<br>Envisiontec or Asiga<br>Systems. | The GR-14 Resin System<br>is intended to be used in<br>conjunction with an<br>additive Computer- Aided<br>Manufacturing (CAM)<br>and curing system such as<br>Nyomo, Rapidshape,<br>Envisiontec or Asiga<br>Systems. | Same | | | Bench Testing<br>(physical<br>property) | Meets the performance<br>standards for Type 4 denture<br>base polymer per ISO<br>20795-1 | Meets the performance<br>standards for Type 4<br>denture base polymer per<br>ISO 20795-1 | Same | | | Biocompatibility | Biocompatible per testing<br>results for all applicable end<br>points per ISO 10993 and<br>ISO 7405 | Biocompatible per testing<br>results for all applicable<br>end points per ISO 10993<br>and ISO 7405 | Same | | | Sterility | Non-Sterile | Non-Sterile | Same | {5}------------------------------------------------ Image /page/5/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. ## DETERMINATION OF SUBSTANTIAL EQUIVALENCE The subject device, Glidewell™ 3DP Denture Base Resin, is substantially equivalent to the primary predicate device, GR-14 Resin System (K210298) in intended use/indications for use and technological characteristics, including technical specifications/features, material and principles of operation. The subject device, Glidewell™ 3DP Denture, has the same intended use as the predicate device, GR-14 Resin System (K210298) as denture base resin. The subject device, Glidewell™ 3DP Denture, has the same Indications for Use Statement (IFUS) {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. as the predicate device, GR-14 Resin System (K210298), except for the device trade name. Both the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298) are light-curable polymerizable resin indicated for the fabrication and repair of full and partial removable dentures and baseplates. Both the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298) are additively manufactured and cured using extraoral curing light equipment. Both the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298) are indicated for prescription use only. The subject device, Glidewell™ 3DP Denture Base Resin, is substantially equivalent to the predicate device, GR-14 Resin System (K210298) in technical features. The subject device. Glidewell™ 3DP Denture Base Resin, was tested according to the test methods defined in the FDA-recognized consensus standard ISO 20795-1 Dentistry -Base polymers – Part 1: Denture base polymers for key physical properties, including flexural strength, flexural modulus, water sorption and water solubility. The testing results showed that the subject device, Glidewell™ 3DP Denture Base Resin met the same performance criterial for Type 4: Light-activated materials set forth in ISO 20795-1 as the predicate device, GR-14 Resin System (K210298). The subject device, Glidewell™ 3DP Denture Base Resin and the predicate device, GR-14 Resin System (K210298) are similar in material composition. Both the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298) are methacrylate-based resins with photo-initiator, stabilizer, filler and pigments. 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™ 3DP Denture Base Resin, is substantially equivalent to the predicate device. GR-14 Resin System (K210298) in terms of principle of operation. Both the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298) are light-cured denture base resin 3D printed using digital light processing (DLP) technology, which involves the lightmediated conversion of a liquid resin containing monomer and oligomer photopolymers to a solid object with the desired physical properties for removable dentures and baseplates. #### VII. PERFORMANCE DATA Non-clinical data submitted to demonstrate substantial equivalence include: - Flexural strength and flexural modulus, according to ISO 20795-1: 2013 . - Water sorption and water solubility, according to ISO 20795-1: 2013 ● - Visual shade match and L*a*b shade verification ● - Printing accuracy and printing orientation validation ● - Packaging validation {7}------------------------------------------------ Image /page/7/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 the word "Prismatik" on top of "Dentalcraft, Inc." - Biocompatibility ● No clinical data is included in this submission. ## Flexural Strength and Flexural Modulus The subject device, Glidewell™ 3DP Denture Base Resin, was tested for flexural strength and flexural modulus in accordance to ISO 20795-1: 2013. The flexural strength for Glidewell™ 3DP Denture Base Resin was tested to be greater than 65 MPa and the flexural modulus was tested to be greater than 2000 MPa, meeting ISO 20795-1: 2013 requirement for Type 4: Light-activated materials. 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™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298). ## Water Sorption and Water Solubility The subject device, Glidewell™ 3DP Denture Base Resin, was tested for water sorption and water solubility in accordance to ISO 20795-1: 2013. The water sorption for Glidewell™ 3DP Denture Base Resin was tested to be less than 32 ug/mm3 and the water solubility was tested to be less than 1.6 ug/mm3, meeting ISO 20795-1: 2013 requirement for Type 4: Light-activated materials. 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™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298). ## Visual Shade Match and L*a*b Shade Verification Visual shade match and L*a*b shade verification were performed on samples of the G1, G3 and G4 shade within a batch and between batches. The results met the acceptance criteria and conformed that the subject device. Glidewell™ 3DP Denture Base Resin, met the color accuracy and consistency requirements for all its different shades. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298). ## Printing Accuracy and Printing Orientation Validation Printing accuracy test was performed to validate that the physical output of the additive manufacturing system and procedure for Glidewell™ 3DP Denture Base Resin is able to meet design input dimensions within the pre-specified tolerance. Printing orientation test was performed to validate that the subject device, Glidewell™ 3DP Denture Base Resin, printed at different print direction within the build space relative to the device orientation and at different build plate locations are able to meet the same performance criteria. The results met the pre-specified acceptance criteria and demonstrated that the subject device, Glidewell™ 3DP Denture Base 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. The results of the testing were used to address questions related to substantial {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with different colors. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the logo. The text is in a blue sans-serif font. equivalence based on differences in additive manufacturing process between the subject device, Glidewell™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298). ### Packaging Validation Packaging validation was also performed for the subject device, Glidewell™ 3DP Denture Base Resin. Per ASTM D4169-14, the shipping unit was tested for manual handling, compressive loads, repetitive shocks from vibration, vertical vibration environments. concentrated impacts and secondary manual handling drops. After the tests, the shipping containers were visually inspected for any damages. It was determined that Glidewell™ 3DP Denture Base Resin with its 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™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298). ### Biocompatibility Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and ISO 14971:2019. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device, Glidewell™ 3DP Denture Base Resin, for its intended use with regard to cytotoxicity, skin sensitization, oral mucosal irritation, genotoxicity, subchronic toxicity, subacute systemic toxicity or systemic (acute) toxicity. 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™ 3DP Denture Base Resin, and the predicate device, GR-14 Resin System (K210298). #### VIII. CONCLUSION Based on technological characteristics and non-clinical test data included in this submission, the subject device, Glidewell™ 3DP Denture Base Resin, has been shown to be substantially equivalent to the predicate device, GR-14 Resin System (K210298).