(85 days)
No
The summary describes a PMMA resin material for dentures and its physical properties and testing, with no mention of AI or ML.
No.
The product is a material (resin) used for manufacturing dentures, not a device that directly performs a therapeutic function on a patient.
No
The device is described as a pigmented polymethyl-methacrylate (PMMA) resin used for manufacturing dentures, not for diagnosing medical conditions. Its intended use is for manufacturing physical products, and the provided information details its composition and non-clinical testing for material properties.
No
The device description clearly states the product is a pigmented polimethyl-methacrilate (PMMA) resin presented in pellets, 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 bases of partial or full removable dentures". This is a manufacturing process for a medical device (dentures), not a diagnostic test performed on a biological sample to provide information about a patient's health.
- Device Description: The device is a "pigmented polimethyl-methacrilate (PMMA) resin" used for manufacturing dentures. This is a material used in the creation of a medical device, not a reagent or instrument used for in vitro testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
Therefore, based on the provided text, Deflex Acrilato is a material used in the manufacturing of dentures, which are medical devices, but it is not an In Vitro Diagnostic device itself.
N/A
Intended Use / Indications for Use
This product is indicated for the manufacturing of bases of partial or full removable dentures, r nis products thatoated for the marketing and pneumatic injection of the material, following the Indications of Use that come with the product.
Product codes
EBI, MQC
Device Description
Deflex Acrilato is a pigmented polimethyl-methacrilate (PMMA) resin that belongs to the group of thermoplastic polymers 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 PMMA 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 *
- Residual MMA monomer content: EN 20795-1:2009 *
- Water absorption: EN 20795-1:2009 *
- Water solubility: EN 20795-1:2009 *
- equivalent to test method described in ANSI+ADA+12-2002+(R2008)
Clinical investigation is not required for this device in order to demonstrate its safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KII3788
510(k) Summary (Rev 01)
(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
(2) Device Proprietary Information
| Trade Name: | DEFLEX ACRILATO |
|---|---|
| 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. | ||
| K102874 | Veracryl | New Stetic |
Device Description (4)
Deflex Acrilato is a pigmented polimethyl-methacrilate (PMMA) resin that belongs to the group of thermoplastic polymers 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 PMMA granules are pigmented so as to achieve aesthetic effects on the manufactured denture.
(5) Intended Use
l
This product is indicated for the manufacturing of bases of partial or full removable dentures, r mis products indication for the mating and pneumatic injection of the material, following the Indications of Use that come with the product.
Comparison to predicate devices (6)
1
Deflex Acrilato is a thermoplastic injectable polymer that belong to the group of the PMMA. As no thermoplastic injectable PMMA could be identified as predicate, the properties of the material were devided into two groups and compared to different predicate devices (all of them having the same intended use), the first one sharing similar indications of use and mechanical properties and the second one sharing similar composition and chemical properties
Intended use, mechanical properties and indications of use have been compared to the following currently marketed thermoplastic injectable material:
| 510(k)
| Number | Trade Name | Manufacturer |
|---|---|---|
| K053060 | TCS unbreakable | Thermoplastic |
| Comfort | ||
| Systems, Inc. |
Intended use, chemical composition and chemical properties have been compared to the following currently marketed thermoplastic injectable material:
| 510(k)
| Number | Trade Name | Manufacturer |
|---|---|---|
| K102874 | Veracryl | New Stetic |
Finding that:
Comparison of Intended Use
- -The two predicates and Deflex Acrilato have the same intended use
Comparison to TCS
- Deflex Acrilato and TCS have similar indications of use •
- Both products show flexible and resilient behavior being DEFLEX ACRILATO more resistant than its predicate
Comparison to Veracryl
- Both materials have been characterized as poly methyl methacrylate -
- Both materials show similar residual MMA monomer content -
- Both materials show similar water absorption and solubility levels -
- Deflex acrilato shows much lower solubility levels than its predicate, which is an indication of long term stability and inert behavior
Considering that both TCS and VERACRYL have essentially the same intended use of DEFLEX ACRILATO, that mechanical properties and indications of use are comparable to those of TCS and AONEATO, that moonanied propenties are comparable to those of VERACRYL, It is our that onemised componion arilato is substantially equivalent to predicate devices in safety and effectiveness.
l :
2
(7) Non Clinical Testing
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 * |
| Residual MMA
monomer content | EN 20795-1:2009 * |
| Water absorption | EN 20795-1:2009 * |
| Water solubility | EN 20795-1:2009 * |
- 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 safety and effectiveness.
Conclusion (9)
NUXEN S.R.L. concludes that DEFLEX ACRILATO Resin for dental prostheses is substantially equivalent to its predicate devices. 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, following the "indications of use" that come with the product.
3
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 stylized eagle with three stripes forming its wing and body. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire-Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Nuxen S.R.L. C/O Mr. Hernan Ilari Consultant IC INGENIERIA J B Justo 9741, PB Buenos Aires, C1408ALB ARGENTINA
Re: K113788
Trade/Device Name: DEFLEX ACRILATO Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI and MQC Dated: March 12, 2012 Received: March 12, 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. Hernan 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 /ucm115809.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,
Anthony V. Watson
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): K//3788
Device Name:
DEFLEX ACRILATO
Indications for Use:
This product is indicated for the manufacturing of bases of partial or full removable dentures, r nis products thatoated for the marketing and pneumatic injection of the material, following the Indications 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)
Page of
Susan Reager
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113781