This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.

Device Description

Deflex is a pigmented granulated polyamide resin that belongs to the group of amorphous polyamides or co polyamides, which is used for the manufacturing of partial, complete and combined dentures. The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging). The polyamide granules are pigmented so as to achieve aesthetic effects on the manufactured denture.

AI/ML Overview

The provided text describes a 510(k) summary for a dental device called DEFLEX, a polymer for the injection of denture bases. This document focuses on demonstrating the device's substantial equivalence to a predicate device (TCS unbreakable) rather than proving performance against specific acceptance criteria in a typical clinical study format.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or provided within this type of regulatory submission, as it's not a performance study in the sense of an AI/human reader study.

However, I can extract information related to the closest equivalent of "acceptance criteria" and "reported device performance" based on the non-clinical testing conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by demonstrating equivalence to the predicate device and meeting relevant established standards. The study "proves" the device meets these criteria by showing it is "at least as safe and effective" as the predicate and compliant with specified test methods.

Test/Property	Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use	Same as predicate (manufacturing bases of partial/full removable dentures, occlusal splints, and night guards).	Same intended use as the predicate device.
Indications of Use	Similar to predicate.	Similar indications of use as the predicate device.
Flexural Strength	Equal to or better than predicate.	"Being DEFLEX more resistant than its predicate." (Implies better flexural strength).
Characterization	Consistent with polyamide family and suitable for dental applications.	"Both materials belong to the polyamide family." Confirmed through `Material Characterization` (Internal laboratory method) and `Mechanical properties` (EN 20795-1:2009 / ANSI+ADA+12-2002+(R2008)).
Swelling	Compliant with EN ISO 10993-13:2009 for biological evaluation of medical devices - Identification and quantification of degradation products.	Tested per EN ISO 10993-13:2009. (Detailed results not provided in summary, but implied to be acceptable for substantial equivalence).
Degradation Products	Compliant with EN ISO 10993-13:2009.	Tested per EN ISO 10993-13:2009. (Implied to be acceptable for substantial equivalence).
In Vitro Cytotoxicity	No significant cytotoxicity.	Tested via Direct Contact (EN ISO 10993-5:2009), Agar Diffusion (EN ISO 7405:2008), and Filter Diffusion (EN ISO 7405:2008). (Implied to be acceptable).
Intracutaneous Reactivity	No significant reactivity.	Tested per EN ISO 10993-10:2010. (Implied to be acceptable).
Delayed Hypersensitivity	No significant hypersensitivity.	Tested per EN ISO 10993-10:2010. (Implied to be acceptable).
Subacute Systemic Toxicity	No significant systemic toxicity.	Tested per EN ISO 10993-11:2009. (Implied to be acceptable).
Genotoxicity (Ames Test)	No genotoxic potential.	Tested per EN ISO 10993-3:2009. (Implied to be acceptable).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not specified in the summary. The non-clinical tests (e.g., mechanical properties, biocompatibility) would have involved defined sample sizes according to the respective standards, but these details are not provided here.
Data Provenance: The tests were carried out by NUXEN S.R.L. and potentially other laboratories (e.g., for biocompatibility tests adhering to ISO standards). The submitter is based in Buenos Aires, Argentina. The data is inherently "retrospective" as it was gathered to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable (N/A). This is a 510(k) summary for a material; it does not involve expert readers establishing ground truth for a diagnostic AI device. The "ground truth" for the non-clinical tests is based on the results of validated laboratory methods and comparison to established standards and the predicate device.

4. Adjudication Method for the Test Set

N/A. No adjudication method is described as this is not a study involving human interpretation of data where consensus is needed for ground truth.

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

N/A. No MRMC or human-in-the-loop study was conducted or required for this device. This is a material for manufacturing, not an AI-powered diagnostic tool.

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

N/A. This device is a material, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by:
- Validated laboratory test methods: Adherence to defined standards (e.g., EN 20795-1:2009, EN ISO 10993 series).
- Comparison to predicate device: The performance of the DEFLEX material is compared directly to the TCS unbreakable resin.
- Material characterization: Internal laboratory methods provide data on the material's properties.

8. The sample size for the training set

N/A. There is no "training set" in the context of this device. This is not an AI or machine learning device. The material itself is "trained" through its manufacturing process and formulation.

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

N/A. See point 8.

Summary

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K113608

Section 5 510(k) Summary

APR 1 0 2012

(1) Submitter:

NUXEN S.R.L.. 1053 Ayacucho, 3rd A (C1111AAE) Ciudad Autónoma de Buenos Aires, Argentina Tel +54 11 4241 7762

Contact person: Pablo Lagostena

Preparation Date: August 1, 2011

Device Proprietary Information (2)

Trade Name:

DEFLEX

Common Name: Polymer for injection of Denture Bases

Classification Name: Denture relining, repairing, or rebasing resin (21 CFR 872.3760, Product Code EBI)

(3) Predicate Devices

510(k)Number	Trade Name	Manufacturer
K053060	TCS unbreakable	ThermoplasticComfortSystems, Inc.

(4) Device Description

Deflex is a pigmented granulated polyamide resin that belongs to the group of amorphous polyamides or co polyamides, which is used for the manufacturing of partial, complete and combined dentures.

The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging).

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The polyamide granules are pigmented so as to achieve aesthetic effects on the manufactured denture.

(5) Intended Use

(6) Comparison to predicate device

Deflex resin and TCS resin have been compared in terms of:

-Intended use
-Indications of use
Flexural strength -
Characterization -

Finding that:

Both products have the same intended use -
-Both products have similar indications of use
Both products have a flexible and resilient behavior being DEFLEX more resistant than its predicate
Both materials belong to the polyamide family -

Arriving to the conclusion that Deflex Resin Material is at least as safe and effective as its predicate device

Non Clinical Testing (7)

The following tests have been carried out in order to demonstrate product's safety and effectiveness

TEST	Standard or TestMethod applied
Materialcharacterization	Internal laboratorymethod
Mechanical properties	EN 20795-1:2009 *
Swelling	EN ISO 10993-13:2009

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Identification andquantification ofdegradation products	EN ISO 10993-13:2009
In Vitro cytotoxicity(Direct Contact Test)	EN ISO 10993-5:2009
In Vitro cytotoxicity(Agar diffusion test)	EN ISO 7405:2008
In Vitro cytotoxicity(Filter diffusion test)	EN ISO 7405:2008
Intra cutaneousreactivity	EN ISO 10993-10:2010
Delayed hypersensitivity	EN ISO 10993-10:2010
Sub acute systemictoxicity test	EN ISO 10993-11:2009
Genotoxicity(AmesTest)	EN ISO 10993-3:2009

equivalent to test method described in ANSI+ADA+12-2002+(R2008)

(8) Clinical Investigation

Clinical investigation is not required for this device in order to demonstrate its safaly and offectiveness.

(9) Conclusion

NUXEN S.R.L. concludes that the DEFLEX Resin for dental prostheses is substantially equivalent to its predicate device. Based upon test data submitted, the product included in this submission can be safely and effectively used for manufacturing bases of partial removable or complete dentures through heating processes and pneumatic injection of the material, according to the technique indicated in the "Use Indications" that come with the product.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

1 & 2012

NUXEN S.R.L. C/O Mr. Hernan Ilari IC Ingenieria 9741 Juan B Justo Buenos Aires ARGENTINA C1408ALB

Re: K113608

Trade/Device Name: DEFLEX Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: April 2, 2012 Received: April 2, 2012

Dear Mr. Ilari:

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. 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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Page 2 - Mr. Ilari

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

DEFLEX

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Shunalmen for msR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113608

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.