(188 days)
Not Found
No
The summary describes a photopolymer resin for 3D printing denture bases. It mentions the use of a CAD/CAM system, 3D scanner, design software, and 3D printer, which are standard components of digital dentistry workflows. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a material (resin) used to fabricate a denture base, which is then used in a therapeutic device (denture). However, the resin itself is not a therapeutic device.
No
The device is a photopolymer resin used for the 3D fabrication of denture bases, which are physical prosthetic devices, not diagnostic tools.
No
The device is a photopolymer resin, which is a physical material used in 3D printing. The summary explicitly describes physical and biocompatible properties testing, indicating it is a hardware component. While it is used within a digital dentistry system, the device itself is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "3D fabrication of denture bases... in dental laboratories." This describes a manufacturing process for a medical device (a denture base), not a diagnostic test performed on a biological sample.
- Device Description: The description focuses on the material (photopolymer resin) and the manufacturing process (3D printing) for creating a physical appliance. It doesn't mention any interaction with biological samples for diagnostic purposes.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a material used in the manufacturing of a medical device (a denture base), which is then used in the oral cavity. This falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
KeyPrint KeyDenture Base is designed for additive manufacturing in vat polymerization 3D printers utilizing wavelengths between 385nm-405nm. KeyDenture Base is indicated for the fabrication of oral denture appliances for fully and partially edentulous patients. KeyDenture Base is intended to be used within a computer-aided and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, and post-cure unit. For any components that are used in conjunction with the KeyDenture Base resin, the user should review all applicable product labeling including Instructions for Use, user manuals, and other associated labeling. Strict adherence to all labeling is critical in assuring a safe and effective printed appliance.
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
dental laboratories
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)
Nonclinical performance testing was conducted for physical and biocompatible properties:
Physical:
Performance of the physical properties of the subject device were completed per ISO 20795-1.2013 - Dentistry - Part 1: Denture base polymers. The following tests were completed successfully:
-Colour stability
-Ultimate Flexural Strength
-Flexural Modulus
-Fracture Toughness
-Residual methyl methacrylate monomer
-Bonding to synthetic teeth
-Water sorption
-Water solubility
Additional performance testing was completed per ASTM D348-14 (tensile properties) and ASTM D648-16 (deflection temperature).
Biocompatibility:
Testing was completed according to ISO 10993, confirming the subject KeyDenture Base is biocompatible and meets the requirements for a permanent (>30 days) device in contact with the mucosal membrane.
Clinical Testing: Not Applicable
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2024
Keystone Industries Caleb Barylski Regulatory Affairs Manager 480 S. Democrat Road Gibbstown, New Jersey 08027
Re: K241089
Trade/Device Name: KeyPrint KeyDenture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: September 26, 2024 Received: September 26, 2024
Dear Caleb Barylski:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Image /page/2/Picture/3 description: The image contains the name "Bobak Shirmohammadi-S". The text is arranged vertically, with "Bobak" on the top line, "Shirmohammadi" on the second line, and "di -S" on the third line. There is a large, light blue graphic on the left side of the image.
For Michael E. Adjodha, M.ChE., RAC, CQIA 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
3
Indications for Use
Submission Number (if known)
Device Name
KeyPrint KeyDenture Base
Indications for Use (Describe)
KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computeraided design and manufacturing (CAD/CAM) system and 3D printer.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K241089 | 510(k) Summary | Prepared on: 2024-09-26 | ||
|---|---|---|---|---|---|
| ----------- | --------- | -- | ---------------- | -- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) | |||
|---|---|---|---|---|
| Applicant Name | Keystone Industries | |||
| Applicant Address | 480 S. Democrat Road Gibbstown NJ 08027 United States | |||
| Applicant Contact Telephone | 856-548-5205 | |||
| Applicant Contact | Mr. Caleb Barylski | |||
| Applicant Contact Email | cbarylski@keystoneind.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | KeyPrint KeyDenture Base | |||
| Common Name | Denture relining, repairing, or rebasing resin | |||
| Classification Name | Resin, Denture, Relining, Repairing, Rebasing | |||
| Regulation Number | 872.3760 | |||
| Product Code(s) | EBI | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K203641 | E-Denture Pro | EBI | ||
| K191427 | Halley Resin System | EBI | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| KeyPrint KeyDenture Base is designed for additive manufacturing in vat polymerization 3D printers utilizing wavelengths between | ||||
| 385nm-405nm. KeyDenture Base is indicated for the fabrication of oral denture appliances for fully and partially edentulous patients. | ||||
| KeyDenture Base is intended to be used within a computer-aided and manufacturing (CAD/CAM) digital dentistry system that includes a | ||||
| 3D scanner, design software, 3D printer, and post-cure unit. For any components that are used in conjunction with the KeyDenture Base | ||||
| resin, the user should review all applicable product labeling including Instructions for Use, user manuals, and other associated labeling. | ||||
| Strict adherence to all labeling is critical in assuring a safe and effective printed appliance. | ||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |||
| KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable | ||||
| dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer. | ||||
| Indications for Use Comparison | ||||
| 21 CFR 807.92(a)(5) |
5
Indications for Use: Similar
The subject and predicate device are both light-curable/photopolymer resins indicated for the fabrication of denture bases using CAD/CAM systems. The subject is indicated for full and partial dentures, while the predicate is for full dentures. The reference device is also indicated for the same fabrication while including full and partial dentures. The indications are similar and do not create a new intended use.
Intended Use: Identical to predicate and reference devices.
Technological Comparison
21 CFR 807.92(a)(6)
Design/Principles of Operation - Similar; the subject device is designed as a denture base for removable full and partial dentures while the predicate is designed for removable full dentures. The reference device is also designed for removable full and partial dentures, using the same materials, similar indications, and same manufacturing methods. The addition of the subject compared to the predicate does not create a new intended use and does not raise issues of safety and effectiveness. Design/Removable - Identical - both subject and predicate are removable dental appliances.
Materials - Identical - both subject and predicate are manufactured from light-curable acrylate resin.
Manufacturing Type - Identical - both subject and predicate utilize additive manufacturing in 3D printers.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
6
Nonclinical performance testing was conducted for physical and biocompatible properties:
Physical:
Performance of the physical properties of the subject device were completed per ISO 20795-1.2013 - Dentistry - Part 1: Denture base polymers. The following tests were completed successfully:
-Colour stability
- -Ultimate Flexural Strength
- -Flexural Modulus
- -Fracture Toughness
- -Residual methyl methacrylate monomer
- -Bonding to synthetic teeth
- -Water sorption
- -Water solubility
Additional performance testing was completed per ASTM D348-14 (tensile properties) and ASTM D648-16 (deflection temperature).
Biocompatibility:
Testing was completed according to ISO 10993, confirming the subject KeyDenture Base is biocompatible and meets the reguirements for a permanent (>30 days) device in contact with the mucosal membrane.
Clinical Testing: Not Applicable
Conclusion of Safety and Effectiveness:
The subject device, KeyDenture Base, has an identical Indications for Use and technological characteristics as the predicate device, E-Denture Pro, and reference, Halley Resin System. Any differences in technology and performance have been tested to determine equivalence to the predicate device, and the information provided herein demonstrates:
· any differences do not raise new questions of safety and effectiveness; and
· the proposed device is at least as safe and effective as the legally marketed predicate device.