(137 days)
No
The summary describes a thermoplastic material and its physical properties, with no mention of AI or ML.
No
The device is a material used in the fabrication of dental prostheses, not a therapeutic device that directly treats a medical condition.
No.
The device is a thermoplastic material used for fabricating dental prostheses, not for diagnosing medical conditions. Its performance studies focus on physical properties, not diagnostic accuracy.
No
The device is a thermoplastic material used in the fabrication of dental prostheses, which is a physical material and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of removable full and partial dental prostheses. This is a material used in the creation of a medical device (the dental prosthesis), not a device used to perform a diagnostic test on a sample from the human body.
- Device Description: The description details a thermoplastic material and the process of heating and injecting it to form a dental prosthesis. This is a manufacturing process for a medical device, not a diagnostic procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers of disease, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties relevant to the structural integrity and suitability of the material for dental prostheses, not on diagnostic accuracy or clinical performance in a diagnostic context.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a material used to construct a medical device that is then placed in the body.
N/A
Intended Use / Indications for Use
Vertex ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
Product codes
EBI
Device Description
Vertex ThermoSens Rigid is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
The Vertex ThermoSens material is incorporated in an aluminium tube, which is heated up to 280 degrees Celsius. After a heating period of 18 minutes, the material is injected into the flask by pressure. The technique can be done in an automatic injection machine or manually. The preparations of the model and flask are according to standard procedures of the dental technique. An instruction for use is in writing, film and pictures available. Also a course can be taken to learn the technique and work with the product.
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)
Physical Properties (ISO 20795-1:2008 Testing).
The physical properties of the Vertex ThermoSens Rigid are equivalent to that of the TCS Unbreakable (K53060) predicate device, as determined by conformance to the ISO 20795-1:2008 testing requirements for dental materials. It is important to note that the Vertex ThermoSens Rigid was tested against TCS Unbreakable predicate by the Sponsor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Impact Strength: 8.0 ± 7.0 kJ/m squared
Flexural modulus: 1339 ± 54 MPa
Water absorption: 31.2 ± 0.8 mug/mm cubed
Water solubility: -0.20 ± 0.25 mug/mm cubed
Maximum stress intensity factor: 3.5 ± 0.3 MPa m1/2
Total fracture work: 160250 ± 16120 J/m squared
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
Submitter: Vertex Dental B.V. Vertex™ ThermoSens Rigid
Premarket Notification: Traditional 510(k)
: : :
510(k) Summary
| Submitter Name: | Vertex Dental B.V. |
|---|---|
| Submitter Address: | Johan van Oldenbarneveltlaan 62 |
| 3705HJ Zeist The Netherlands | |
| Phone Number: | 0031 306 976 780 |
| Fax Number: | 0031 306 955 188 |
| Contact Person: | Mason Diamond, DDS |
| Date Prepared: | January 17, 2013 |
| Device Trade Name: | Vertex™ ThermoSens Rigid |
| Common Name | Denture base material |
| Classification Name, | |
| Number & | |
| Product Code: | resin, denture, relining, repairing, rebasing |
| 872.3760 | |
| EBI | |
| Predicate Devices: | TCS® Unbreakable - K053060 (Thermoplastic Comfort Systems, |
| Inc.) | |
| Lucitone® FRS™ Flexible Dental Resin - K992956 (Densply | |
| International) | |
| Device Description | |
| and Statement of | |
| Indications For Use | Device Description: |
| Vertex™ ThermoSens Rigid is a thermoplastic material that is | |
| intended to be used in the fabrication of removable full and partial | |
| dental prostheses. The product is based on a compounded | |
| mixture of Polyamide and pigments. | |
| The Vertex™ ThermoSens material is incorporated in an | |
| aluminium tube, which is heated up to 280 degrees Celsius. After | |
| a heating period of 18 minutes, the material is injected into the | |
| flask by pressure. The technique can be done in an automatic | |
| injection machine or manually. The preparations of the model and | |
| flask are according to standard procedures of the dental | |
| technique. An instruction for use is in writing, film and pictures | |
| available. Also a course can be taken to learn the technique and | |
| work with the product. |
1
Indications For Use:
Vertex™ ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments All of the components found in the Vertex™ ThermoSens Rigid Summary of denture base material have been used in legally marketed Technological devices and were found acceptable for dental use. Characteristics The Vertex™ ThermoSens Rigid denture base material is Substantial substantially equivalent to TCS Unbreakable (K053060) with Equivalence respect to Indication for Use, Intended Use and Physical Properties (according to ISO 20795-1:2008 standard); and substantially equivalent to Lucitone® FRS™ Flexible Dental Resin - K992956 with respect to Composition. As a result of this analysis, the Vertex™ ThermoSens Rigid poses the same types of questions about safety or effectiveness as the existing predicate device. Indications for Use/Intended Use As presented in the table below, even though there is variation in the wording between the Vertex™ ThermoSens Rigid compared to the predicated devices, TCS Unbreakable (K53060) and Lucitone® FRS™ Flexible Dental Resin (K992956), the proposed device has the same Intended Use and similar Indications for Use statement. As a result of Indication for Use and Intended Use, the Vertex™ ThermoSens Rigid is Substantially Equivalent to that of the predicate devices. Composition of Polymer As presented in the table below, the Polyamide 12 polymer in the Vertex™ ThermoSens Rigid is the same as that in the Lucitone® FRS™ Flexible Dental Resin (K992956). As a result of Composition of Polymer, the Vertex ™ ThermoSens Rigid is Substantially Equivalent to that of the predicate device. Physical Properties (ISO 20795-1:2008 Testing) As presented in the table below, the physical properties of the Vertex™ ThermoSens Rigid are equivalent to that of the TCS Unbreakable (K53060) predicate device, as determined by conformance to the ISO 20795-1:2008 testing requirements for dental materials. It is important to note that the Vertex ™ ThermoSens Rigid was tested against TCS Unbreakable predicate by the Sponsor, and while the Lucitone® FRS™ Flexible Dental Resin (K992956) was not included in this tesing. As a result of the Physical Properties evaluation, the Vertex™ ThermoSens Rigid is Substantially Equivalent to that of the predicate devices.
2
| Submitter: | Vertex™ ThermoSens Rigid |
|---|---|
| Vertex Dental B.V. | Premarket Notification: Traditional 510(k) |
The information discussed above demonstrates that the Vertex™ Conclusion ThermoSens Rigid denture base material is substantially equivalent to the predicate devices.
:
3
Submitter:
Vertex Dental B.V.
| Feature | Vertex™ ThermoSens Rigid | TCS Unbreakable | Lucitone® FRS™ Flexible Dental Resin |
|---|---|---|---|
| 510(k) Number | Not yet assigned | K053060 | K992956 |
| Manufacturer | Vertex Dental B.V. | Thermoplastic Comfort | |
| Systems, Inc. | Densply International | ||
| Classification # & | |||
| Product Code | 872.3760 | ||
| EBI | 872.3760 | ||
| EBI | 872.3760 | ||
| EBI | |||
| Indications for Use | Vertex™ ThermoSens is a | ||
| thermoplastic material that is | |||
| intended to be used in the fabrication | |||
| of removable full and partial dental | |||
| prostheses. The product is based on | |||
| a compounded mixture of Polyamide | |||
| and pigments. | TCS® Unbreakable is a break | ||
| resistant material used in the | |||
| fabrication and repair of base | |||
| plates for removeable dental | |||
| prosthetic appliances where | |||
| superior flexibility and patient | |||
| comfort for the lifetime of the | |||
| prosthetic are significant | |||
| concerns. This includes, but | |||
| not to be limited to, full and | |||
| partial dentures, orthodontic | |||
| devices, occlusal splints, and | |||
| night guards. | Used for fabrication of | ||
| partial or full removable | |||
| dentures, as well as | |||
| occlusal splints and | |||
| nightguards. | |||
| Intended Use | Fabrication of removable dental | ||
| prosthetic devices, such as full and | |||
| partial dentures. | Fabrication and repair of | ||
| removable dental prosthetic | |||
| devices, such as full and | |||
| partial dentures, orthodontic | |||
| devices, occlusal splints, and | |||
| night guards. | Fabrication of partial or full | ||
| removable dentures, as | |||
| well as occlusal splints and | |||
| nightguards. | |||
| Composition of | |||
| Polymer | Polyamide 12 | Polyamide 12 | Polyamide 12 |
| Physical Properties | |||
| (ISO 20795-1:2008 | |||
| requirement) | Not Tested by | ||
| Sponsor. | |||
| Impact Strength (≥ | |||
| 7.0 kJ/m²) | 8.0 ± 7.0 kJ/m² | 8.5 ± 1.2 kJ/m² | |
| Flexural modulus (≥ | |||
| 1000 MPa) | 1339 ± 54 MPa | 353 ± 4.24 MPa | |
| Water absorption (≤ | |||
| 32.0 µg/mm³): | 31.2 ± 0.8 µg/mm³ | 14.6 ± 0.4 µg/mm³ | |
| Water solubility | |||
| (≤1.6 µg/mm³): | -0.20 ± 0.25 µg/mm³ | 2.5 ± 0.7 µg/mm³ | |
| Maximum stress | |||
| intensity factor (≥ 2.5 | |||
| MPa m1/2) | 3.5 ± 0.3 MPa m1/2 | ||
| Total fracture work | |||
| (≥ 125000 J/m²) | 160250 ± 16120 J/m² |
Summary of Technical Characteristics
Section 5.0: 510(k) Summary
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 1, 2013
Vertex-Dental B.V. C/O Mason Diamond, DDS Vice President, Regulatory and Quality Affairs Oserve America 154 Main Street, Suite #2 · CHARLESTOWN NH 03603
Re: K123220
Trade/Device Name: Vertex ThermoSens Rigid Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 25, 2012 Received: February 21, 2013
Dear Dr. Diamond:
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.
5
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" in bold black font, with the letters partially obscured by a faded, geometric FDA logo in the background. The word "for" is written in a smaller, lighter font to the right of the name. The logo appears to be a stylized version of the FDA acronym.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Submitter: Vertex Dental
Vertex™ ThermoSens Rigid Premarket Notification: Traditional 510(k)
Indications for Use
510(k) Number (if known): K123220
Vertex™ ThermoSens Rigid Device Name:
Indications For Use:
Vertex™ ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
Prescription Use × AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Mary S. Runner | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| Susan Runner DDSRA | |
| 2013.02.28 | |
| 10:30:16 -05'00' |
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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Section 4.0