(56 days)
Not Found
No
The summary describes a light-cured resin for fabricating dental appliances and includes performance data related to material properties and printing accuracy. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a resin used for fabricating orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints, and repositioners, which are therapeutic in nature.
No
Explanation: The device is described as a light-cured resin for the fabrication of orthodontic and dental appliances. Its intended use is for creating physical devices like bite planes, mouthguards, and splints, not for diagnosing medical conditions. The performance studies focus on mechanical properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a light-cured resin for fabrication of physical dental appliances, which is a material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating orthodontic and dental appliances like bite planes, mouthguards, etc. These are devices used in the mouth for mechanical or protective purposes.
- Device Description: The device is a light-cured resin used for 3D printing or molding these dental appliances.
- Lack of Diagnostic Purpose: There is no mention of this device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are specifically designed for diagnostic purposes.
The information provided clearly describes a material used to create a medical device that is placed in the mouth, not a diagnostic test.
N/A
Intended Use / Indications for Use
Glidewell™ Appliance Resin. Hard/Soft is indication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
Device Description
Glidewell™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted to demonstrate substantial equivalence include:
- Flexural strength and flexural modulus, according to ISO 20795-2
- 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
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.
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.
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.
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.
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.
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.
No clinical data is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KeyPrint KeySplint Soft Resin (K183598)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the 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
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) 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
| Technological
Characteristics | Subject Device
Glidewell™ Appliance
Resin, Hard/Soft | Predicate Device
KeyPrint KeySplint Soft
Resin (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 and
dental appliances | Resin for orthodontic and
dental appliances | Same | |
| 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. | 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. | |
| Design
Characteristics | General Design | Light-cured resin using 3D
printing technology
or combination of 3D
printing and injection
molding 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. | The subject device uses
3D printing technology
to convert the liquid
resin to solid
orthodontic and dental
appliances, same as the
predicate device.
The only difference is
that the subject device
has the additional
option of fabricating a
dual-layered device
through 3D printing of
the hard outer layer
with the hard resin and
injection molding of
the soft inner layer with
the soft resin. |
| Technological
Characteristics | Subject Device
Glidewell™ Appliance
Resin, Hard/Soft | Predicate Device
KeyPrint KeySplint Soft
Resin (K183598) | Comparison | |
| Material
composition | Light cured methacrylate
based-resin. | Light cured methacrylate
based-resin. | Substantially
equivalent | |
| Additive
Manufacturing
System | Glidewell™ Appliance
Resin, Hard/Soft 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 | |
| Bench Testing
(physical
property) | Physical properties
according to:
ISO 20795-2:
Flexural Strength,
Flexural
Modulus, Water
Sorption/SolubilityASTM D638:
Tensile Strength,
Tensile Modulus,
Elongation | Physical properties
according to:
ASTM D790:
Flexural PropertiesISO 20795-2:
Flexural Strength,
Flexural Modulus,
Water
Sorption/SolubilityASTM D638:
Tensile Strength,
Tensile Modulus,
Elongation | The predicate device
was tested for flexural
properties according to
ASTM D790 in
addition to ISO 20795-
2. | |
| 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 | |
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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).