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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device called "FREEPRINT denture." It focuses on bench testing and biocompatibility studies to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based device that would typically involve a test set, ground truth experts, and MRMC studies.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets these criteria cannot be fully extracted or answered from the provided document. The document describes a physical medical device (denture resin), not an AI/ML system.

However, I can extract the details about the performance testing and acceptance criteria as described for this physical device.

Here's an interpretation based on the provided text, acknowledging it's for a physical product and not an AI/ML device:

Device: FREEPRINT denture (light-cured resin for denture bases)

Type of Study: Bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device. No clinical tests were performed.

1. A table of acceptance criteria and the reported device performance

For a physical material like dental resin, acceptance criteria are typically defined by recognized standards (like ISO) and relate to physical, chemical, and biological properties.

Acceptance Criteria Category (Referenced Standard)	Reported Device Performance (Summary)
Physical/Mechanical Properties
Strength, Resistance to Compressive & Tensile Loads	Sufficient strengths and performances in all intraoral conditions.
Hardness	Sufficient hardness.
Water Sorption	Sufficient resistance to water sorption.
Solubility	Sufficient resistance to solubility.
Biocompatibility (ISO 10993-3, -5, -10, -11, -17; ISO 7405)	Insolubility is in compliance with requirements. No evidence of hazardous effects from leachable ingredients/contaminants.
Printer Compatibility	Four specified 3D printers are validated for processing FREEPRINT denture.

Proof of Meeting Acceptance Criteria:
"Performance testing confirmed the FREEPRINT denture demonstrated performance to the acceptance criteria referred to ISO 20795-1."
"Biocompatibility testing...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."

2. Sample sized used for the test set and the data provenance

Sample Size: Not explicitly stated for each specific test (e.g., how many samples were tested for water sorption). The document generally states "Bench testing was carried out."
Data Provenance: Not explicitly stated for test samples (e.g., country of origin). The device manufacturer is DETAX GmbH & Co.KG. in Germany, implying testing likely occurred in a similar region. The studies are retrospective in the sense that they are conducted on manufactured samples of the device and its components, not involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert interpretation of images or data to establish ground truth. "Ground truth" in this context refers to measurements against established standards for material science.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images for AI/ML development. For material performance testing, results are typically objective measurements against a standard.

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 a physical device, not an AI/ML system. No human readers or interpretations of results in the context of an MRMC study are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance relies on established international standards (e.g., ISO 20795-1 for dental base polymers, ISO 10993 series for biocompatibility), and the objective measurements of the material's properties against the specifications within these standards.

8. The sample size for the training set

Not Applicable. This is a physical dental material, not an AI/ML device that requires a training set. The material is manufactured and tested according to specified processes and properties.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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

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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)
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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 4D-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-componentmaterials for the Digital Light Processing (DLP)-printing ofdenture base products. It is stored in 500 and 1000ml HDPEbottles. This Product is a liquid photo-curable material that ispolymerized, by the photo-initiator contained in the resin. Thisdevice can be manufactured with 3D stereolithographicprinter with 385nm wavelength light source. Curing in a 3Dprinter is related to the conditions of the printer equipmentand is typically 100µm in thickness. FREEPRINT dentureproducts are post cured with a xenon flashlight, in a nitrogenatmosphere.
Physical Description:	FREEPRINT denture: dimethacrylate based resin1-component system.Processed (3D printed) using 385nm light source.
V. INTENDED USE /INDICATION FOR USESTATEMENT	FREEPRINT denture is a light-cured resin indicated for thefabrication of all types of denture bases, for instance full andpartial removable dentures.FREEPRINT denture is intended for continuous use in theoral environment, exclusively for professional dental work.FREEPRINT denture can be used in combination with astereolithographic 3D printer using a 385nm light source. A3D-printer is not part of the device.
VI SUMMARY OF
PREDICATE DEVICESIndications for UseandTechnologicalCharacteristics:	FREEPRINT denture has a similar Indications for Usestatement as the predicate device.The FREEPRINT denture has the following similarities in thetechnological characteristics to the predicate device,NextDent™ Denture/E-Denture, Vertex-Dental BV(K162572):- Same type of materials (chemical composition) thatform the basis for the device used- Same technology, however different wavelength usedfor polymerization (Curing) method- Similar mechanical and physical properties ofprocessed device.
Summary of PerformanceData and DesignControls:	Bench testing was carried out on the followingcharacteristics:• Printers validationFour printers are validated for processing (3D printing) usingFREEPRINT denture. Additional printers post-510(k)-clearance will be added to the labelling by means of theQuality Systems and within the validation plan presented inthis 510(k).
	Referenced Standards and Performance Testing:Performance testing confirmed the FREEPRINT denturedemonstrated performance to the acceptance criteria referredto ISO 20795-1.The composition of FREEPRINT denture exhibits sufficientstrengths and performances in all intraoral conditions and willsufficiently resist compressive & tensile loads, hardness,water sorption and solubility.
	Biocompatibility testing:FREEPRINT denture was tested with respect tobiocompatibility according to ISO 10993-3, ISO 10993-5, ISO10993-10, ISO 10993-11 and ISO 10993-17, taking ISO 7405into account. The results showed that the insolubility is incompliance with the requirements of the standard. There isno evidence that hazardous effects will arise by leachableingredients/contaminants.
	Clinical TestsNo clinical tests were performed with FREEPRINT denture
Sterility and Shelf-LifeTesting:	SterilizationFREEPRINT denture is provided non-sterile.
	From the Shelf-life testing, FREEPRINT denture has a shelflife of two years.
VIII. CONCLUSION OFSUBSTANTIAL	FREEPRINT denture and the predicate have the sameintended 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.

Regulation Number and Section

§ 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.