(137 days)
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.
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.
The provided document is a 510(k) summary for the Vertex™ ThermoSens Rigid denture base material. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study that establishes specific acceptance criteria and then proves the device meets those criteria through performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typically relevant for AI/ML device evaluations or detailed clinical trials) is not applicable to this 510(k) submission.
This submission demonstrates substantial equivalence by comparing the new device's Indications for Use, Intended Use, Composition of Polymer, and Physical Properties to those of predicate devices (TCS® Unbreakable - K053060 and Lucitone® FRS™ Flexible Dental Resin - K992956). The "acceptance criteria" here are essentially the properties and characteristics of the predicate devices, and the "study" is a comparative analysis and laboratory testing against established ISO standards.
Here's how the provided information can be structured based on the request, acknowledging the limitations inherent in a 510(k) substantial equivalence submission:
1. Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a material like a denture base, the "acceptance criteria" are typically defined by recognized standards (like ISO 20795-1:2008 for dental materials) and the performance of predicate devices. The device "meets" these criteria by demonstrating similar properties to the predicates and conforming to the standard.
| Acceptance Criterion (from ISO 20795-1:2008 / Predicate Device) | Vertex™ ThermoSens Rigid Performance | Predicate Device (TCS Unbreakable) Performance |
|---|---|---|
| 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 | Not explicitly provided for predicate |
| Total fracture work (≥ 125000 J/m²) | 160250 ± 16120 J/m² | Not explicitly provided for predicate |
Note: For "Maximum stress intensity factor" and "Total fracture work", specific predicate values were not provided in the table, but the device's performance is presented against the ISO requirement. For other properties, comparisons are made to TCS Unbreakable. The Lucitone® FRS™ predicate was noted as "Not Tested by Sponsor" for physical properties.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the 510(k) summary. The physical properties testing would have involved material samples, but the number of samples for each test is not detailed.
- Data Provenance: The testing was performed by the "Sponsor" (Vertex Dental B.V.). The country of origin for the data is implicitly The Netherlands, where Vertex Dental B.V. is located. This is laboratory-based testing on material samples, not patient data, so "retrospective or prospective" is not applicable in the usual clinical sense.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a material substantial equivalence submission based on laboratory physical property testing and comparison to existing devices and standards, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for Test Set
- Not Applicable. See point 3. Testing involves material property measurements, not expert consensus on findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a material safety and performance submission, not an AI-assisted diagnostic or triaging device.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This is a physical product (denture base material), not a software algorithm.
7. Type of Ground Truth Used
- Laboratory Measurements against ISO Standard and Predicate Performance: The "ground truth" for the physical properties is defined by the requirements of the ISO 20795-1:2008 standard for dental materials and the measured performance of predicate devices. For composition and indications, the ground truth is established by the specifications of the predicate devices.
8. Sample Size for Training Set
- Not Applicable. This is a physical product, not a machine learning model requiring a training set. The material itself is the "product," and its properties are measured directly.
9. How Ground Truth for Training Set was Established
- Not Applicable. See point 8.
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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 623705HJ 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, rebasing872.3760EBI |
| Predicate Devices: | TCS® Unbreakable - K053060 (Thermoplastic Comfort Systems,Inc.)Lucitone® FRS™ Flexible Dental Resin - K992956 (DensplyInternational) |
| Device Descriptionand Statement ofIndications For Use | Device Description:Vertex™ ThermoSens Rigid is a thermoplastic material that isintended to be used in the fabrication of removable full and partialdental prostheses. The product is based on a compoundedmixture of Polyamide and pigments.The Vertex™ ThermoSens material is incorporated in analuminium tube, which is heated up to 280 degrees Celsius. Aftera heating period of 18 minutes, the material is injected into theflask by pressure. The technique can be done in an automaticinjection machine or manually. The preparations of the model andflask are according to standard procedures of the dentaltechnique. An instruction for use is in writing, film and picturesavailable. Also a course can be taken to learn the technique andwork with the product. |
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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.
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| 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.
:
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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 ComfortSystems, Inc. | Densply International |
| Classification # &Product Code | 872.3760EBI | 872.3760EBI | 872.3760EBI |
| Indications for Use | Vertex™ ThermoSens is athermoplastic material that isintended to be used in the fabricationof removable full and partial dentalprostheses. The product is based ona compounded mixture of Polyamideand pigments. | TCS® Unbreakable is a breakresistant material used in thefabrication and repair of baseplates for removeable dentalprosthetic appliances wheresuperior flexibility and patientcomfort for the lifetime of theprosthetic are significantconcerns. This includes, butnot to be limited to, full andpartial dentures, orthodonticdevices, occlusal splints, andnight guards. | Used for fabrication ofpartial or full removabledentures, as well asocclusal splints andnightguards. |
| Intended Use | Fabrication of removable dentalprosthetic devices, such as full andpartial dentures. | Fabrication and repair ofremovable dental prostheticdevices, such as full andpartial dentures, orthodonticdevices, occlusal splints, andnight guards. | Fabrication of partial or fullremovable dentures, aswell as occlusal splints andnightguards. |
| Composition ofPolymer | Polyamide 12 | Polyamide 12 | Polyamide 12 |
| Physical Properties(ISO 20795-1:2008requirement) | Not Tested bySponsor. | ||
| 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 stressintensity factor (≥ 2.5MPa 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
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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.
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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
§ 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.