(126 days)
Not Found
No
The summary describes a material (polyamide resin) and its intended use in manufacturing dentures and splints. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on material properties and biocompatibility.
No.
This device is a material (pigmented granulated polyamide resin) used for manufacturing dental prostheses like dentures, occlusal splints, and night guards. It is not an active therapeutic device designed to treat a medical condition directly.
No
Explanation: The device is a polyamide resin used for manufacturing dentures, not for diagnosing medical conditions.
No
The device description clearly states it is a pigmented granulated polyamide resin used for manufacturing dentures, which is a physical material, 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 manufacturing of dental prosthetics (dentures, splints, night guards). This is a manufacturing process for a medical device that will be used in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a material (polyamide resin) used to create the dental prosthetics. It's not a reagent, instrument, or system used for in vitro testing.
- Performance Studies: The performance studies focus on the material's properties, safety, and biocompatibility when used in the body (cytotoxicity, reactivity, toxicity). These are typical tests for implantable or body-contacting medical devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, this device is a material used in the manufacturing of dental prosthetics, which are medical devices used within the body. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
EBI
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.
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
Not Found
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
Non Clinical Testing: The following tests have been carried out in order to demonstrate product's safety and effectiveness: Material characterization (Internal laboratory method), Mechanical properties (EN 20795-1:2009), Swelling (EN ISO 10993-13:2009), Identification and quantification of degradation 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 cutaneous reactivity (EN ISO 10993-10:2010), Delayed hyper sensitivity (EN ISO 10993-10:2010), Sub acute systemic toxicity test (EN ISO 10993-11:2009), Genotoxicity (Ames Test) (EN ISO 10993-3:2009).
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.
0
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 | Thermoplastic |
| Comfort | ||
| 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).
1
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
Method applied |
|------------------------------|------------------------------------|
| Material
characterization | Internal laboratory
method |
| Mechanical properties | EN 20795-1:2009 * |
| Swelling | EN ISO 10993-13:2009 |
2
| Identification and
quantification of
| degradation 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 cutaneous | |
| reactivity | EN ISO 10993-10:2010 |
| Delayed hyper | |
| sensitivity | EN ISO 10993-10:2010 |
| Sub acute systemic | |
| toxicity test | EN ISO 10993-11:2009 |
| Genotoxicity(Ames | |
| 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.
3
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.
4
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
5
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