(90 days)
No
The document describes a resin material used in 3D printing, with no mention of AI models for any functionality. The "CAD/CAM digital dentistry system" refers to a workflow, not specifically to AI within the device itself.
No
The device is a resin used to fabricate dental prosthetics (flexible partial dentures), which are medical devices, but the resin itself is a material for manufacturing, not a therapeutic device.
No
This device is a material (resin) for fabricating flexible partial dentures in dental laboratories, not a device used to diagnose medical conditions. Its use is in the manufacturing process of a medical device, not in diagnostics.
No
The device description clearly states "FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures". This indicates it is a physical material (a resin), not a software-only product. It is intended for additive manufacturing on 3D printers and is subject to physical and biocompatibility testing, further confirming it is a physical device, not a software-only medical device.
No
The device is a resin used to create dental prosthetics, which are physical devices. IVDs are used to examine specimens derived from the human body.
N/A
Intended Use / Indications for Use
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
Product codes
EBI
Device Description
The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.
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 - Base polymers - Part 1: Denture base polymers. The following tests were completed for this submission:
- Colour stability
- Ultimate Flexural Strength
- Flexural Modulus
- Water sorption
- Water solubility
Additional performance testing was completed per ASTM D348 (tensile properties) and ASTM D790 (flexural modulus).
Biocompatibility:
Testing was completed according to ISO 10993, confirming the subject FP3D 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - K250489
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 20, 2025
Keystone Industries
Autumn Mcclure
Regulatory Specialist
480 S. Democrat Road
Gibbstown, New Jersey 08027
Re: K250489
Trade/Device Name: FP3D
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture Relining, Repairing, Or Rebasing Resin
Regulatory Class: Class II
Product Code: EBI
Dated: February 19, 2025
Received: February 19, 2025
Dear Autumn Mcclure:
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/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.
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K250489 - Autumn Mcclure
Page 2
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" (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 QS 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 (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-reporting-combination-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 bear a unique 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250489 - Autumn Mcclure
Page 3
assistance/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,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, 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
Page 4
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Submission Number (if known) |
|---|
| K250489 |
| Device Name |
|---|
| FP3D |
Indications for Use (Describe)
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Page 5
510(k) Summary
510(k)#: K250489
Prepared on: 2025-05-19
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 | 856-548-5036 |
| Applicant Contact | Ms. Autumn McClure |
| Applicant Contact Email | amcclure@keystoneind.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | FP3D |
|---|---|
| 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 |
|---|---|---|
| K241089 | KeyDenture Base | EBI |
| K063626 | DuraFlex | EBI |
Device Description Summary
21 CFR 807.92(a)(4)
The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Indications for Use: Similar.
The subject and predicate device are both 3D fabricated denture resins indicated for the fabrication of denture bases using CAD/CAM systems. The subject device is a dual cure resin while the predicate device is a photopolymer resin. The subject device is indicated for partial dentures while the predicate is for full or partial dentures. The subject device is indicated for flexible partial dentures whereas the predicate device does not indicate flexibility. The increased flexibility of the subject is provided for comfort and patient experience while using the device and does not change the intended use. The indications are similar and do not create a new intended use.
Page 6
Intended Use: Identical to predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Design/Principles of Operation - Similar; the subject device is designed as a flexible removal partial denture while the predicate is designed as a removable full or partial denture. The reference device is also designed as a flexible removable partial denture with similar indications. The removal of the full denture with 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 - Similar- both subject and predicate are manufactured from light-curable acrylate resin. The subject device consists of a part A acrylate resin and a part B diamine-based resin. This mixture is at a 10:1 ratio (Part A:Part B). The differences in materials do not raise issues of safety and effectiveness.
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)
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 - Base polymers - Part 1: Denture base polymers. The following tests were completed for this submission:
- Colour stability
- Ultimate Flexural Strength
- Flexural Modulus
- Water sorption
- Water solubility
Additional performance testing was completed per ASTM D348 (tensile properties) and ASTM D790 (flexural modulus).
Biocompatibility:
Testing was completed according to ISO 10993, confirming the subject FP3D is biocompatible and meets the requirements for a permanent (>30 days) device in contact with the mucosal membrane.
Clinical Testing:
Not Applicable
Conclusion of Safety and Effectiveness:
The subject device, FP3D, has an identical Intended Use and similar Indications for Use and technological characteristics as the predicate device, KeyDenture Base, and reference, Dura Flex. 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.