DEFLEX

K113608 · Nuxen S.R.L. · EBI · Apr 10, 2012 · Dental

Device Facts

• Record ID: K113608
• Device Name: DEFLEX
• Applicant: Nuxen S.R.L.
• Product Code: EBI · Dental
• Decision Date: Apr 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

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 Story

Deflex is a pigmented granulated polyamide resin used for manufacturing partial, complete, and combined dentures, occlusal splints, and night guards. The material is supplied in pellets within vacuum-sealed packaging. The manufacturing process involves heating and pneumatic injection of the resin to form the desired dental appliance. The device is intended for use by dental professionals in a laboratory or clinical setting. The resulting denture bases provide a flexible and resilient alternative to traditional materials. The device benefits patients by enabling the creation of durable, aesthetic, and functional removable dental prostheses.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through bench testing, including material characterization, mechanical property testing (EN 20795-1:2009), swelling, degradation product identification, and a comprehensive suite of biocompatibility tests (cytotoxicity, intracutaneous reactivity, delayed hypersensitivity, systemic toxicity, and genotoxicity).

Technological Characteristics

Pigmented granulated polyamide resin (amorphous/co-polyamide). Form factor: pellets. Processing: heating and pneumatic injection. Standards: EN 20795-1:2009 (mechanical properties), EN ISO 10993-13:2009 (swelling/degradation), EN ISO 10993-5:2009/7405:2008 (cytotoxicity), EN ISO 10993-10:2010 (reactivity/hypersensitivity), EN ISO 10993-11:2009 (systemic toxicity), EN ISO 10993-3:2009 (genotoxicity).

Indications for Use

Indicated for manufacturing bases of partial or full removable dentures, occlusal splints, and night guards in patients requiring dental prosthetics.

Regulatory Classification

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.

Predicate Devices

• TCS unbreakable (K053060)

Submission Summary (Full Text)

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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 [phone]

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)<br>Number | Trade Name | Manufacturer |
|------------------|-----------------|-------------------------------------------|
| K053060 | TCS unbreakable | Thermoplastic<br>Comfort<br>Systems, 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

.

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.

## (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 Test<br>Method applied |
|------------------------------|------------------------------------|
| Material<br>characterization | Internal laboratory<br>method |
| Mechanical properties | EN 20795-1:2009 * |
| Swelling | EN ISO 10993-13:2009 |

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| Identification and<br>quantification of<br>degradation products | EN ISO 10993-13:2009 |
|-----------------------------------------------------------------|----------------------|
| In Vitro cytotoxicity<br>(Direct Contact Test) | EN ISO 10993-5:2009 |
| In Vitro cytotoxicity<br>(Agar diffusion test) | EN ISO 7405:2008 |
| In Vitro cytotoxicity<br>(Filter diffusion test) | EN ISO 7405:2008 |
| Intra cutaneous<br>reactivity | EN ISO 10993-10:2010 |
| Delayed hyper<br>sensitivity | EN ISO 10993-10:2010 |
| Sub acute systemic<br>toxicity test | EN ISO 10993-11:2009 |
| Genotoxicity(Ames<br>Test) | 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 [phone] or [phone] 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:

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.

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)

of Page

Shunalmen for msR

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

510(k) Number: K113608