The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades.

AI/ML Overview

Here's an analysis of the provided text regarding the Vertex Dental B.V. Vertex hot-curing denture base material, focusing on acceptance criteria and study details.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (from predicate devices / ISO standards)	Vertex Rapid Simplified Performance
Charpy impact strength	≥ 1.36 kj/m² (from predicate devices)	11.3 kj/m²
Flexural strength	≥ 78 MPa (from predicate devices)	85 MPa
Flexural modulus	≥ 2367 MPa (from predicate devices)	2367 MPa
Water absorption	≤ 22.0 µg/mm³ (from predicate devices)	22.5 µg/mm³
Water solubility	≤ 1.5 µg/mm³ (from predicate devices)	0.11 µg/mm³
Residual monomer	< 2.2% (from predicate devices)	1.33 ± 0.16%

Note: The acceptance criteria are inferred from the performance data of the predicate devices (Probase Hot and Major.Base 20) against which the Vertex Rapid Simplified is compared for substantial equivalence, and by referring to the ISO 1567 standard. The document states that the material complies with ISO 1567, implying these values meet or exceed the standard's requirements.

2. Sample size used for the test set and the data provenance

The provided 510(k) summary does not explicitly state the sample sizes used for the material property tests. It provides mean values and, in some cases, standard deviations, but not the 'n' value for the number of samples tested for each property.

The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer to demonstrate compliance with standards and equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the described study is a series of material property tests, not a clinical study involving expert interpretation or ground truth establishment in a medical context.

4. Adjudication method for the test set

This information is not applicable as the described study is a series of material property tests, not a clinical study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission concerns a dental material's physical and chemical properties, not a medical imaging or AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This submission concerns a dental material, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the established physical and chemical property testing standards (e.g., ISO 1567, ISO 179-1, ISO 20795, ISO 7405, ASTM F 895-84). The device's performance is measured against these objective standards and compared to legally marketed predicate devices, which are also compliant with these standards.

8. The sample size for the training set

This information is not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

This information is not applicable. As stated above, this is not a machine learning or AI-based device.

Summary

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Submitter: Vertex Dental B.V. Vertex hot-curing denture base material Premarket Notification: Traditional 510(k)

K102654

510(k) Summary

Submitter Name:Submitter Address:	Vertex Dental B.V.
Phone Number:	603 369 3550
Fax Number:	603 369 3562
	DEC - 3 2010
Contact Person:	William Greenrose
Date Prepared:	August 9, 2010
Device Trade Name:	Vertex Rapid Simplified
Common Name	Denture base material
Classification Name,Number &Product Code:	resin, denture, relining, repairing, rebasing872.3760EBI
Predicate Devices:	Probase Hot (K913655), Major.Base 20 (K081884)
Device Descriptionand Statement ofIntended Use	Device Description: The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades.Intended Use:The Vertex Rapid Simplified is indicated for:1. Fabrication of full dentures

in -Pabrication of full Gentures
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Submitter:Vertex Dental B.V.	Vertex hot-curing denture base materialPremarket Notification: Traditional 510(k)	Feature	Vertex hot-curingdenture base material	Probase Hot	Major.Base 20
Summary ofTechnologicalCharacteristics	All of the components found in Vertex™ hot-curing denture basematerials have been used in leqally marketed devices and were foundsafe for dental use.	510(k) Number	Not yet assigned	K913655	K081884
SubstantialEquivalence	The Vertex hot-curing denture base material is substantially equivalentto the Probase Hot (K913655) and Major Base 20 (K081884), withrespect to mode of action and intended use. It is substantially equivalentto the Probase Cold (K913655) and Major.Base 20 (K081884) denturebase materials, with respect to material of composition. The submitteddevice pose the same types of questions about safety or effectivenessas the existing device.		Manufacturer	Vertex Dental B.V.	Ivoclar North America, Inc.	Major Prodotti Dentari S.p.a
Conclusion	The information discussed above demonstrates that the Vertex hot-curing denture base material is substantially equivalent to the predicatedevices.		Classification #& ProductCode	872.3760EBI	872.3760EBI	872.3760EBI
Declarations	This summary includes only information that is also covered in the0body of the 510(k).This summary does not contain any puffery or unsubstantiated0labeling claims.This summary does not contain any raw data, i.e., contains only0summary data.This summary does not contain any trade secret or confidential0commercial·information.This summary does not contain any patient identification information.০	Indications forUse	The Vertex RapidSimplified is indicated for:3. Fabrication of fulldentures4. Fabrication ofpartial dentures	Partial and combinationdentures, conventionalor implant supportedComplete denturesHybrid denturesRelines of conventionalor implant dentures	Major.Base 20 is a denturebase polymer for dentalprosthesis. Poly-methylmethacrylate based.Heat-processed polymer.Powder and liquid.It is used for:Dental prosthesisPartial prosthesisClasp prosthesis
Composition ofMaterials	Powder:Polymethyl methacrylate,Benzoyl peroxide,PigmentsLiquid:Methyl methacrylate,Ethyleneglycoldimethacrylate, N,N-dimethyl-4-toluidine,Tinuvin P	Powder:Polymethylmethacrylate, softeningagent, benzoylperoxide, pigmentsLiquid:Methyl methacrylate,dimethacrylate (linkingagent), catalyst	Powder:Poly-methylmethacrylate,PigmentsLiquid:Methyl methacrylate,Ethyleneglycoldimethacrylate, N,N-dimethyl-p-toluidine,Benzophenone-3
PhysicalProperties	Charpy impact strength:11.3 kj/m²flexural strength: 85 MPaflexural modulus: 2367MPawater absorption: 22.5µg/mm³water solubility: 0.11µg/mm³Residual monomer: 1.33 ±0.16%	Charpy impact strength:1.36 kj/m²± 0.09flexural strength 87.4 ±8.9 (MPa)flexural modulus 2904.9± 281.4 (MPa)Residual monomer:<2.2%	Charpy impact strength:1.36 kj/m²±0.03flexural strength: 78 MPaflexural modulus: 2390 MPawater absorption: 22.0µg/mm³water solubility: 1.5 µg/mm³Residual monomer: 1.8%
Standards ofConformity	ISO 1567ISO 20795ISO 179-1ISO 7405ASTM F 895-84	ISO 1567	ISO 1567

Section 5.0: 510(k) Summary

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and the comments of the comments of the comments of the comments of

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Submitter: Vertex Dental B.V.

Summary of Technical Characteristics : .

Section 5.0: 510(k) Summary

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vertex Dental B.V. C/O Mr. William Greenrose Regulatory Consultant Qserve America, Incorporated 22 River Road Claremont, New Hampshire 03743

DEC - 3 2010

Re: K102654

Trade/Device Name: Vertex™ Rapid Simplified Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 13, 2010 Received: September 14, 2010

Dear Mr. Greenrose:

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 - Mr. Greenrose

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony 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

510(k) Number (if known):

Device Name: Vertex™ Rapid Simplified

14102654

Indications For Use:

The Vertex Rapid Simplified is indicated for:

1. Fabrication of full dentures

Fabrication of partial dentures

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices age 1 of 1

510(k) Number: K102654

Section 4.0

Regulation Number and Section

§ 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.