(56 days)
Glidewell™ Appliance Resin, Hard/Soft is indication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
Glidewell™ Appliance Resin, Hard/Soft is a light-cured resin for fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners. The Glidewell™ Appliance Resin. Hard and the Glidewell Appliance Resin, Soft can be used in combination to create a dual layer device consisting of a 3D printed hard layer, made from Glidewell™ Appliance Resin, Hard, and a soft layer that is molded with Glidewell Appliance Resin, Soft. The Glidewell™ Appliance Resin, Hard can also be used alone to create a 3D printed single layer device. The Glidewell™ Appliance Resin, Hard is compatible with DLP printers utilizing a wavelength of 385nm.
This is a 510(k) summary for a dental resin, not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details (such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document discusses the substantial equivalence of the Glidewell™ Appliance Resin, Hard/Soft to a predicate device (KeyPrint KeySplint Soft Resin). The "acceptance criteria" in this context refer to the performance thresholds for physical properties and biocompatibility tests, rather than diagnostic accuracy or AI model performance.
Here's a breakdown of the relevant information provided, adapted to the context of a dental material rather than an AI device:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Context):
The document states that "All the testing results met the acceptance criteria" for the following tests, indicating the device performed satisfactorily according to established standards. Specific numerical acceptance criteria and reported numerical performance values are not provided in this summary, but the summary confirms successful adherence to them.
| Test Type | Standard Applied | Acceptance Criteria (Summary confirms met) | Reported Device Performance (Summary confirms met) |
|---|---|---|---|
| Physical Properties | |||
| Flexural Strength | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Flexural Modulus | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Water Sorption | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Water Solubility | ISO 20795-2 | Met predetermined criteria | Met predetermined criteria |
| Tensile Strength | ASTM D638 | Met predetermined criteria | Met predetermined criteria |
| Tensile Modulus | ASTM D638 | Met predetermined criteria | Met predetermined criteria |
| Elongation | ASTM D638 | Met predetermined criteria | Met predetermined criteria |
| Printing Accuracy | Based on design input | Met pre-specified tolerance | Met pre-specified tolerance |
| Printing Orientation Validation | Based on performance criteria | Met same performance criteria | Met same performance criteria |
| Biocompatibility | ISO 10993-1 | No biocompatibility concern | No biocompatibility concern |
| Packaging Validation | ASTM D4169-14 | Suitable for use | Suitable for use |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary for each specific test (e.g., how many specimens for flexural strength). It broadly states "All the testing results" met the criteria.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer or a contracted lab. The document does not mention country of origin or whether it's retrospective/prospective data, as these concepts are not typically relevant for material property testing in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a material science and biocompatibility assessment, not a diagnostic device requiring expert interpretation of results to establish ground truth. Ground truth is established by standardized physical/chemical measurements and biological assays against defined limits.
4. Adjudication method for the test set:
- Not Applicable. No adjudication process is described as the tests are objective material property measurements.
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 not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used:
- Objective Measurement against Standards: For physical properties, ground truth is established by precise laboratory measurements against the requirements and limits defined in standards like ISO 20795-2 and ASTM D638. For biocompatibility, ground truth is established by standardized biological tests (e.g., cytotoxicity, sensitization) according to ISO 10993-1, with results interpreted against established safety thresholds.
8. The sample size for the training set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI device.
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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2022
Prismatik Dentalcraft, Inc. Jiahe Li Regulatory Affairs Specialist 2144 Michelson Drive Irvine, California 92612
Re: K214102
Trade/Device Name: Glidewell Appliance Resin, Hard/Soft Regulatory Class: Unclassified Product Code: MQC, KMY Dated: December 27, 2021 Received: December 29, 2021
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) K214102
Device Name Glidewell™ Appliance Resin, Hard/Soft
Indications for Use (Describe)
Glidewell™ Appliance Resin. Hard/Soft 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) X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 SubpartC)
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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient that starts with pink at the top and transitions to blue at the bottom. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a sans-serif font.
K214102
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(a)glidewelldental.com Phone: (949) 222-3516
Secondary Contact Person: Herbert Crane, VP RA/QA Email: Herbert.Crane(@glidewelldental.com Phone: (949) 222-3531
Date Prepared: December 27, 2021
II. DEVICE
Name of Device: Glidewell™ Appliance Resin, Hard/Soft 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
III. PREDICATE DEVICE
KeyPrint KeySplint Soft Resin (K183598)
IV. DEVICE DESCRIPTION
Glidewell™ Appliance Resin, Hard/Soft is a light-cured resin for fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners. The Glidewell™ Appliance Resin. Hard and the Glidewell Appliance Resin, Soft can be used in combination to create a dual layer device consisting of a 3D printed hard layer, made from Glidewell™ Appliance Resin, Hard, and a soft layer that is molded with Glidewell Appliance Resin, Soft. The Glidewell™ Appliance Resin, Hard can also be used alone to create a 3D printed single layer device. The Glidewell™ Appliance Resin, Hard is compatible with DLP printers utilizing a wavelength of 385nm.
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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, purple, blue, and yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.
V. INDICATIONS FOR USE
Glidewell™ Appliance Resin, Hard/Soft is indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| TechnologicalCharacteristics | Subject DeviceGlidewell™ ApplianceResin, Hard/Soft | Predicate DeviceKeyPrint KeySplint SoftResin (K183598) | Comparison | |
|---|---|---|---|---|
| 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 anddental appliances | Resin for orthodontic anddental appliances | Same | |
| Indications for Use | Glidewell™ ApplianceResin, Hard/Soft isindicated for thefabrication oforthodontic and dentalappliances such as biteplanes, mouthguards,nightguards, splints andrepositioners. | The KeyPrint KeySplintSoft device is indicated forthe fabrication oforthodontic and dentalappliances such as biteplanes, mouthguards,nightguards, splints andrepositioners. | The indications for useare the same except forthe device trade name. | |
| DesignCharacteristics | General Design | Light-cured resin using 3Dprinting technologyor combination of 3Dprinting and injectionmolding to convert theliquid resin to solidorthodontic and dentalappliances. | Light-cured resin using 3Dprinting technology toconvert the liquid resin tosolid orthodontic anddental appliances. | The subject device uses3D printing technologyto convert the liquidresin to solidorthodontic and dentalappliances, same as thepredicate device.The only difference isthat the subject devicehas the additionaloption of fabricating adual-layered devicethrough 3D printing ofthe hard outer layerwith the hard resin andinjection molding ofthe soft inner layer withthe soft resin. |
| TechnologicalCharacteristics | Subject DeviceGlidewell™ ApplianceResin, Hard/Soft | Predicate DeviceKeyPrint KeySplint SoftResin (K183598) | Comparison | |
| Materialcomposition | Light cured methacrylatebased-resin. | Light cured methacrylatebased-resin. | Substantiallyequivalent | |
| AdditiveManufacturingSystem | Glidewell™ ApplianceResin, Hard/Soft isintended to be used inconjunction with anadditive Computer-Aided Manufacturing(CAM) and curingsystem. | The KeyPrint KeySplintSoft device is intended tobe used in conjunctionwith an additiveComputer- AidedManufacturing (CAM) andcuring system. | Same | |
| Bench Testing(physicalproperty) | Physical propertiesaccording to:ISO 20795-2:Flexural Strength,FlexuralModulus, WaterSorption/SolubilityASTM D638:Tensile Strength,Tensile Modulus,Elongation | Physical propertiesaccording to:ASTM D790:Flexural PropertiesISO 20795-2:Flexural Strength,Flexural Modulus,WaterSorption/SolubilityASTM D638:Tensile Strength,Tensile Modulus,Elongation | The predicate devicewas tested for flexuralproperties according toASTM D790 inaddition to ISO 20795-2. | |
| Biocompatibility | Biocompatible pertesting results accordingto ISO 10993-1 | Biocompatible per testingresults according to ISO10993-1 | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same |
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Image /page/5/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, purple, blue, and yellow. 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™ Appliance Resin, Hard/Soft, 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.
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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 a sans-serif font, with the words "PRISMATIK" and "DENTALCRAFT, INC." stacked on top of each other.
The subject device, Glidewell™ Appliance Resin, Hard/Soft, 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™ Appliance Resin, Hard/Soft, 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™ Appliance Resin, Hard/Soft, and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are dental resins indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
The subject device. Glidewell™ Appliance Resin. Hard/Soft, is substantially equivalent to the predicate device, KeyPrint KeySplint Soft Resin (K183598) in technical specifications/features. The product specifications of the subject device, Glidewell™ Appliance Resin, Hard/Soft, is based on benchmarking comparable 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 and ASTM D638 that applied to the predicate device, KeyPrint KeySplint Soft Resin (K183598), were performed on the subject device, Glidewell™ Appliance Resin, Hard/Soft, including flexural strength, flexural modulus, water sorption, water solubility, tensile strength, tensile modulus and elongation. The physical property of the subject device, Glidewell™ Appliance Resin, Hard/Soft, passed the threshold of performance criteria in ISO 20795-2 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™ Appliance Resin, Hard/Soft and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are similar in material composition. Both the subject device. Glidewell™ Appliance Resin. Hard/Soft, 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™ Appliance Resin, Hard/Soft, is substantially equivalent to the predicate device, KeyPrint KeySplint Soft Resin (K183598) in terms of principle of operation. Both the subject device, Glidewell™ Appliance Resin, Hard/Soft, and the predicate device, KeyPrint KeySplint Soft Resin (K183598) are light-cured 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:
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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 "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
- Flexural strength and flexural modulus, according to ISO 20795-2
- Water sorption and water solubility, according to ISO 20795-2 ●
- Tensile Strength, Tensile Modulus and Elongation, according to ASTM D638 ●
- Printing Accuracy and Printing Orientation Validation ●
- Packaging validation ●
- . Biocompatibility
No clinical data is included in this submission.
Flexural Strength and Flexural Modulus
The subject device, Glidewell™ Appliance Resin, Hard/Soft, was tested for flexural strength and flexural modulus in accordance with the test methods outlined in ISO 20795-2. 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™ Appliance Resin, Hard/Soft, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
Water Sorption and Water Solubility
The subject device, Glidewell™ Appliance Resin, Hard/Soft, was tested for water sorption and water solubility in accordance with ISO 20795-2. 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™ Appliance Resin, Hard/Soft, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
Tensile Strength, Tensile Modulus and Elongation
The subject device, Glidewell™ Appliance Resin, Hard/Soft, was tested for tensile strength, tensile modulus and elongation in accordance with ASTM D638. 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, GlidewellTM Appliance Resin, Hard/Soft, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
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™ Appliance Resin. Hard are able to meet design input dimensions within the pre-specified tolerance. 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 are able to meet the same performance criteria. The results met the pre-specified acceptance criteria and demonstrated that the subject device. Glidewell™ Appliance Resin. Hard/Soft, 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.
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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular prism on the left and the company name on the right. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
Packaging Validation
Packaging validation was performed for the subject device, Glidewell™ Appliance Resin, Hard/Soft. 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. It was determined that Glidewell™ Appliance Resin, Hard/Soft 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™ Appliance Resin. Hard/Soft, and the predicate device, KeyPrint KeySplint Soft Resin (K183598).
Biocompatibility
The subject device, Glidewell™ Appliance Resin, Hard/Soft, was tested in accordance with ISO 10993-1. 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™ Appliance Resin, Hard/Soft, 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™ Appliance Resin, Hard/Soft, has been shown to be substantially equivalent to the predicate device. KeyPrint KeySplint Soft Resin (K183598).
N/A