(265 days)
Not Found
No
The device description and performance studies focus on the material properties and manufacturing process of a light-cured resin for dentures, with no mention of AI or ML technologies.
Yes
The device is a material for fabricating denture bases which are prosthetic devices used to restore oral function and aesthetics, thus serving a therapeutic purpose.
No
Explanation: The device is a light-cured resin intended for the fabrication of denture bases, which is a manufacturing material, not a diagnostic tool.
No
The device description clearly states it is a light-cured resin material, which is a physical substance, 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 the fabrication of denture bases for full and partial removable dentures. This is a medical device used for creating a prosthetic, not for diagnosing a condition or obtaining information about a physiological state.
- Device Description: The description details a light-cured resin for 3D printing dentures. This aligns with the description of a material used in the manufacturing of a medical device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information.
- Anatomical Site: The "oral environment" is where the final product (the denture) is used, not where a diagnostic test is performed by this specific device.
- Performance Studies: The performance studies focus on the material's properties (strength, hardness, water sorption, solubility) and biocompatibility, which are relevant to a medical device intended for long-term oral use, not to the accuracy or reliability of a diagnostic test.
In summary, the device is a material used to manufacture a medical device (dentures), not a device that performs a diagnostic function.
N/A
Intended Use / Indications for Use
FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 3D-printer is not part of the device.
Product codes
EBI
Device Description
FREEPRINT denture is a light-cured one-component materials for the Digital Light Processing (DLP)-printing of denture base products. It is stored in 500 and 1000ml HDPE bottles. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength light source. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 100µm in thickness. FREEPRINT denture products are post cured with a xenon flashlight, in a nitrogen atmosphere.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral environment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental work
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
Bench testing was carried out on the following characteristics:
• Printers validation
Four printers are validated for processing (3D printing) using FREEPRINT denture. Additional printers post-510(k)-clearance will be added to the labelling by means of the Quality Systems and within the validation plan presented in this 510(k).
Referenced Standards and Performance Testing: Performance testing confirmed the FREEPRINT denture demonstrated performance to the acceptance criteria referred to ISO 20795-1. The composition of FREEPRINT denture exhibits sufficient strengths and performances in all intraoral conditions and will sufficiently resist compressive & tensile loads, hardness, water sorption and solubility.
Biocompatibility testing: FREEPRINT denture was tested with respect to biocompatibility according to ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11 and ISO 10993-17, taking ISO 7405 into account. The results showed that the insolubility is in compliance with the requirements of the standard. There is no evidence that hazardous effects will arise by leachable ingredients/contaminants.
Clinical Tests: No clinical tests were performed with FREEPRINT denture
Sterility and Shelf-Life Testing: Sterilization: FREEPRINT denture is provided non-sterile. From the Shelf-life testing, FREEPRINT denture has a shelf life of two years.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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November 16, 2020
Detax GmbH & Co. KG % Jan-Paul Van Loon Consultant Qserve Consultancy BV. Utrechtseweg 310 - Bldg B42 Arnhem, Gelderland 6812 AR Netherlands
Re: K200461
Trade/Device Name: Freeprint denture Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: October 19, 2020 Received: October 20, 2020
Dear Jan-Paul Van Loon:
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
1
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 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 medical devices and radiation-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 Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200461
Device Name FREEPRINT denture
Indications for Use (Describe)
FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 3Dprinter is not part of the device.
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) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K200461 - 510(k) Summary
| I SUBMITTER | |
|---|---|
| Submitter Name: | DETAX GmbH & Co.KG. |
| Submitter Address: | Carl-Zeiss-Stasse 4 |
| D-76275 Ettingen Germany | |
| Phone Number: | +49 (0)7243/510-138 |
| Contact Person: | M. (Markus) Stratmann |
| Date Prepared: | February 6, 2020 |
| II. DEVICE | |
| Device Trade Name: | FREEPRINT denture |
| Common Name | Denture relining, repairing, or rebasing resin |
| Classification | 21 CFR 872.3760 |
| Product Code: | EBI |
| Review Panel: | Dental |
| III. PREDICATE DEVICE | K162572, NextDent™ Denture/E-Denture, Vertex-Dental BV., |
| IV. DEVICE DESCRIPTION | |
| Description | FREEPRINT denture is a light-cured one-component |
| materials for the Digital Light Processing (DLP)-printing of | |
| denture base products. It is stored in 500 and 1000ml HDPE | |
| bottles. This Product is a liquid photo-curable material that is | |
| polymerized, by the photo-initiator contained in the resin. This | |
| device can be manufactured with 3D stereolithographic | |
| printer with 385nm wavelength light source. Curing in a 3D | |
| printer is related to the conditions of the printer equipment | |
| and is typically 100µm in thickness. FREEPRINT denture | |
| products are post cured with a xenon flashlight, in a nitrogen | |
| atmosphere. | |
| Physical Description: | FREEPRINT denture: dimethacrylate based resin |
| 1-component system. | |
| Processed (3D printed) using 385nm light source. | |
| V. INTENDED USE / | |
| INDICATION FOR USE | |
| STATEMENT | FREEPRINT denture is a light-cured resin indicated for the |
| fabrication of all types of denture bases, for instance full and | |
| partial removable dentures. | |
| FREEPRINT denture is intended for continuous use in the | |
| oral environment, exclusively for professional dental work. | |
| FREEPRINT denture can be used in combination with a | |
| stereolithographic 3D printer using a 385nm light source. A | |
| 3D-printer is not part of the device. | |
| VI SUMMARY OF | |
| PREDICATE DEVICES | |
| Indications for Use | |
| and | |
| Technological | |
| Characteristics: | FREEPRINT denture has a similar Indications for Use |
| statement as the predicate device. | |
| The FREEPRINT denture has the following similarities in the | |
| technological characteristics to the predicate device, | |
| NextDent™ Denture/E-Denture, Vertex-Dental BV | |
| (K162572): |
- Same type of materials (chemical composition) that
form the basis for the device used - Same technology, however different wavelength used
for polymerization (Curing) method - Similar mechanical and physical properties of
processed device. |
| Summary of Performance
Data and Design
Controls: | Bench testing was carried out on the following
characteristics:
• Printers validation
Four printers are validated for processing (3D printing) using
FREEPRINT denture. Additional printers post-510(k)-
clearance will be added to the labelling by means of the
Quality Systems and within the validation plan presented in
this 510(k). |
| | Referenced Standards and Performance Testing:
Performance testing confirmed the FREEPRINT denture
demonstrated performance to the acceptance criteria referred
to ISO 20795-1.
The composition of FREEPRINT denture exhibits sufficient
strengths and performances in all intraoral conditions and will
sufficiently resist compressive & tensile loads, hardness,
water sorption and solubility. |
| | Biocompatibility testing:
FREEPRINT denture was tested with respect to
biocompatibility according to ISO 10993-3, ISO 10993-5, ISO
10993-10, ISO 10993-11 and ISO 10993-17, taking ISO 7405
into account. The results showed that the insolubility is in
compliance with the requirements of the standard. There is
no evidence that hazardous effects will arise by leachable
ingredients/contaminants. |
| | Clinical Tests
No clinical tests were performed with FREEPRINT denture |
| Sterility and Shelf-Life
Testing: | Sterilization
FREEPRINT denture is provided non-sterile. |
| | From the Shelf-life testing, FREEPRINT denture has a shelf
life of two years. |
| VIII. CONCLUSION OF
SUBSTANTIAL | FREEPRINT denture and the predicate have the same
intended use and similar technological characteristics. |
VI. SUMMARY OF TECHNOLOGICAL CHRACHTERISTICS OF DEVICE COMPARED TO
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The results of the performed tests show that FREEPRINT EQUIVALENCE denture meets the requirements mentioned in the applicable standards, and confirm that the device performs similarly to the predicate device.
It is therefore concluded that FREEPRINT denture is substantially equivalent to the predicate device.