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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Glidewell™ 3DP Denture Base Resin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from ISO 20795-1: 2013 for Type 4 Light-activated materials)	Reported Device Performance (Glidewell™ 3DP Denture Base Resin)	P-value/Statistical Significance (if available)
Flexural Strength	> 65 MPa	> 65 MPa	Not specified
Flexural Modulus	> 2000 MPa	> 2000 MPa	Not specified
Water Sorption	< 32 µg/mm³	< 32 µg/mm³	Not specified
Water Solubility	< 1.6 µg/mm³	< 1.6 µg/mm³	Not specified
Visual Shade Match	Met acceptance criteria (accuracy and consistency)	Met acceptance criteria	Not specified
Lab Shade Verification	Met acceptance criteria (accuracy and consistency)	Met acceptance criteria	Not specified
Printing Accuracy	Met pre-specified tolerance for design input dimensions	Met pre-specified acceptance criteria	Not specified
Printing Orientation	Able to meet same performance criteria at different print directions/locations	Met pre-specified acceptance criteria	Not specified
Packaging Integrity	Shipping containers visually inspected for no damages after tests	Deemed suitable for use	Not specified
Biocompatibility	No biocompatibility concern per ISO 10993-1:2018 and ISO 14971:2019	No biocompatibility concern for all applicable endpoints	Not specified

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each test set (e.g., how many samples were tested for flexural strength, how many batches for shade match).

Provenance: The data is non-clinical performance data generated by Prismatik Dentalcraft, Inc. The document does not specify country of origin for the data, but the company is based in Irvine, California, USA, and the tests were performed according to international standards (ISO). The studies are retrospective as they present results of completed tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a material (resin) that undergoes physical, chemical, and biological testing against established international standards rather than requiring expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on established physical, chemical, and biological measurement protocols outlined in the ISO standards. The results are quantitative measurements compared against predefined numerical limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a material (resin) for dental applications, not an AI diagnostic or assistive device for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material testing, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance of the Glidewell™ 3DP Denture Base Resin is based on consensus international standards. Specifically, ISO 20795-1: 2013 "Dentistry - Base polymers – Part 1: Denture base polymers" defines the performance criteria for physical properties, and ISO 10993-1:2018 and ISO 14971:2019 define the requirements for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is a material, not a machine learning algorithm that requires a training set. The "training" for the material would be the research and development process to formulate the resin to meet the performance characteristics.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this isn't an AI device with a training set. The "ground truth" for the material's development would be the target performance specifications derived from market needs, clinical requirements, and relevant standards.

Summary

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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. 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

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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

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Indications for Use

510(k) Number (if known)

K213765

Device Name Glidewell™ 3DP Denture Base Resin

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CER 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. 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

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.

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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.

TechnologicalCharacteristics	Subject DeviceGlidewell™ 3DP DentureBase Resin	Predicate DeviceGR-14 Resin System(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 partialand full denture	Denture base resin forpartial and full denture	Same
Indications for Use	Glidewell™ 3DP DentureBase Resin is a light-curablepolymerizable resin intendedto be used in conjunctionwith extraoral curing lightequipment. Glidewell™ 3DPDenture Base Resin isindicated for the fabricationand repair, by additivemanufacturing, of full andpartial removable denturesand baseplates.	The GR-14.1 denture is alight-curablepolymerizable resinintended to be used inconjunction with extraoralcuring light equipment.The GR-14.1 denture isindicated for thefabrication and repair, byadditive manufacturing,of full and partialremovable dentures andbaseplates.The GR-14.2 denture HIis a light-curablepolymerizable resinintended to be used inconjunction with extraoralcuring light equipment.The GR-14.2 denture HIis indicated for thefabrication and repair, byadditive manufacturing,of full and partialremovable dentures andbaseplates.	Only the trade namesare different betweenthe subject device,Glidewell™ 3DPDenture Base Resin,and the predicatedevice, GR-14 ResinSystem (K210298).The second part of theIndications for Usestatement for thepredicate device, GR-14 Resin System(K210298) is the sameas the first part, exceptfor the change in thetrade name from GR-14.1 to GR-14.2denture HI. Therepeated part is notincluded in the case ofthe subject device,Glidewell™ 3DPDenture Base Resin.,as it would beredundant.
TechnologicalCharacteristics		Subject DeviceGlidewellTM 3DP DentureBase Resin	Predicate DeviceGR-14 Resin System(K210298)	Comparison
DesignCharacteristics	General Design	Light-cured denture baseresin using 3D printingtechnology to convert theliquid resin to solid denturesand baseplates	Light-cured denture baseresin using 3D printingtechnology to convert theliquid resin to soliddentures and baseplates	Same
	Materialcomposition	Methacrylate/dimethacrylate-based resins with photo-initiator, stabilizer, filler andpigments.	Methacrylate/dimethacrylates, photo-initiator, stabilizer, fillerand pigments.	Substantiallyequivalent
	AdditiveManufacturingSystem	GlidewellTM 3DP DentureBase Resin is intended to beused in conjunction with anadditive Computer- AidedManufacturing (CAM) andcuring system such asNyomo, Rapidshape,Envisiontec or AsigaSystems.	The GR-14 Resin Systemis intended to be used inconjunction with anadditive Computer- AidedManufacturing (CAM)and curing system such asNyomo, Rapidshape,Envisiontec or AsigaSystems.	Same
	Bench Testing(physicalproperty)	Meets the performancestandards for Type 4 denturebase polymer per ISO20795-1	Meets the performancestandards for Type 4denture base polymer perISO 20795-1	Same
	Biocompatibility	Biocompatible per testingresults for all applicable endpoints per ISO 10993 andISO 7405	Biocompatible per testingresults for all applicableend points per ISO 10993and ISO 7405	Same
	Sterility	Non-Sterile	Non-Sterile	Same

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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)

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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.

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 Lab shade verification ●
Printing accuracy and printing orientation validation ●
Packaging validation

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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 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 Lab Shade Verification

Visual shade match and Lab 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

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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).

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.