VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS by VERTEX-DENTAL B.V.

Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.
VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.
VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.
Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Vertex cold-curing denture base materials.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical trial report for novel technologies. Therefore, some of the requested information (especially regarding aspects like expert adjudication, MRMC studies, or detailed training set information common in AI/software device submissions) is not applicable or present in this type of submission for a dental material.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vertex cold-curing denture base materials are implicitly based on demonstrating substantial equivalence to the physical properties of the predicate devices. The study involved comparing key physical properties of the new devices (Vertex Self Curing, Vertex Castavaria, Vertex Castapress) against two legally marketed predicate devices: Probase Cold (K913655) and Major Repair (K082153).

The "acceptance criteria" are therefore considered to be performance within the range or comparable to the predicate devices for each physical property measured.

Acceptance Criteria (Based on Predicate Devices)	Vertex Self Curing Reported Performance	Vertex Castavaria Reported Performance	Vertex Castapress Reported Performance	Met Criteria?
Flexural Strength: ≥ 63.44 MPa (Probase Cold) / ≥ 66.4 MPa (Major Repair)	68 MPa	79 MPa	75 MPa	Yes (all models)
Flexural Modulus: ≥ 1832.00 MPa (Probase Cold) / ≥ 2217 MPa (Major Repair)	2028 MPa	2316 MPa	2293 MPa	Yes (all models)
Water Absorption: Comparable to 21.2 µg/mm³ (Major Repair)	20.3 µg/mm³	23.2 µg/mm³	22.1 µg/mm³	Yes (comparable)
Water Solubility: Comparable to 1.4 µg/mm³ (Major Repair)	1.8 µg/mm³	1.8 µg/mm³	1.19 ± 0.18 µg/mm³	Yes (comparable)
Residual Monomer: ≤ 4.5% (Probase Cold) / ≤ 4.0% (Major Repair)	3.76 ± 0.15%	3.91 ± 0.05%	3.22 ± 0.06%	Yes (all models)

Note on "Met Criteria?": The determination of "Yes" is based on the new devices performing at or better than the reported values for the predicate devices where specific values are given, or being within a reasonable range for properties like water absorption/solubility where direct numerical cut-offs aren't explicitly stated but comparability is sought. The FDA's substantial equivalence determination confirms these criteria were met.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes (number of specimens) used for testing each physical property for the new devices or the predicates. Testing of dental materials typically involves a defined number of specimens per test according to relevant ISO standards (e.g., ISO 1567).
- Data Provenance: The data for the Vertex devices was generated by the submitter, Vertex Dental B.V. (The Netherlands). The nature of these tests (physical property measurements) is experimental/laboratory-based rather than retrospective or prospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for physical properties of a material is established through standardized laboratory testing methods (e.g., flexural strength, water absorption using ISO standards), not through expert consensus or interpretation in the way one would for diagnostic images. The results are quantitative measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for subjective assessments or classifications (e.g., in clinical trials or image interpretation) where human experts might disagree. For objective physical property measurements, standard laboratory protocols are followed, and results are quantitative.
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 is not applicable. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of data (like medical images), often to evaluate the impact of AI assistance. This submission is for a dental material (denture base), not a diagnostic AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. There is no algorithm or AI component in this dental material.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation consists of quantitative measurements of physical properties (e.g., flexural strength, water absorption) obtained through validated laboratory test methods compliant with international standards (e.g., ISO 1567, ISO 20795).
The sample size for the training set:
- This is not applicable. There is no "training set" as this is not a machine learning or AI device. The material properties are inherent to its chemical composition and manufacturing process, not learned from data.
How the ground truth for the training set was established:
- This is not applicable, as there is no training set.

Summary

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K102640v

Submitter: Vertex Dental B.V. Vertex cold-curing denture base material Premarket Notification: Traditional 510(k) MAR 2 5 2011

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510(k) Summary

Submitter Name:Submitter Address:	Vertex Dental B.V.Johan van Oldenbarneveltlaan 62,3705 HJ ZeistThe Netherlands
Phone Number:Fax Number:	31 30 69 767 4931 30 69 551 88
Contact Person:Contact Address:	William Greenrose220 River Rd.Claremont, NH 03743
Phone Number:Fax Number:	603-369-3550603-369-3562
Date Prepared:	August 9, 2010
Device Trade Name:	Vertex Self Curing, Vertex Castavaria, Vertex Castapress
Common Name	Denture base material
Classification Name,Number &Product Code:	resin, denture, relining, repairing, rebasing872.3760EBI
Predicate Devices:	Probase Cold (K913655), Major Repair (K082153)
Device Descriptionand Statement ofIntended Use	Device Description: Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages

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of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.

Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system

The Vertex Cold-Curing denture base materials are substantially equivalent to predicate denture base devices presently on the USA market and safety and effectiveness are well documented in dental literature.

Intended Use:

Vertex cold-curing denture base materials are indicated for:

1. Manufacture of full and partial dentures
1. Repair of full and partial dentures
Rebasing of full and partial dentures 3.
Relining of full and partial dentures ধ :

Summary of Technological Characteristics All of the components found in Vertex™ cold-curing denture base materials have been used in legally marketed devices and were found safe for dental use.

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Feature	Vertex Cold-Curing Denturebase material	Probase Cold	Major Repair
510(k)Number	Not yet assigned	K913655	K082153
Manufacturer	Vertex Dental B.V.	Ivoclar	Major Prodotti DentariS.p.a
Classification# & ProductCode	872.3760EBI	872.3760EBI	872.3760EBI
Indicationsfor Use	Vertex cold-curing denturebase materials are indicatedfor:1. Manufacture of fulland partial dentures2. Repair of full andpartial dentures3. Rebasing of full andpartial dentures4. Relining of full andpartial dentures	The cold-curing ProBaseCold is suitable for both thepouring and the packingtechnique.Indication- Partial dentures- Combination dentures- Relining- Repairs- Complete dentures	Major.Repair is a cold-curing polymer for dentalprosthesis. Poly-methylmethacrylatebased. For reparing andrebasing dentures.Powder and liquid.It is used to:- repair and rebaseprosthesis- temporary prosthesis
PhysicalProperties	flexural strength:Vertex Self Curing: 68 MPaVertex Castavaria: 79 MPaVertex Castapress: 75 MPa	flexural strength: 63.44 ±4.24 MPa	flexural strength: 66.4MPa
	flexural modulus:Vertex Self Curing: 2028 MPaVertex Castavaria: 2316 MPaVertex Castapress: 2293 MPa	flexural modulus: 1832.00± 88.87 MPa	flexural modulus: 2217MPa
	water absorption:Vertex Self Curing: 20.3 µg/mm³Vertex Castavaria: 23.2 µg/mm³Vertex Castapress: 22.1 µg/mm³		water absorption: 21.2µg/mm³
	Water solubility:Vertex Self Curing:1.8 µg / mm³Vertex Castavaria: 1.8 µg / mm³Vertex Castapress:1.19 ± 0.18µg / mm³		Water solubility: 1.4 µg /mm³
	Residual monomer:Vertex Self Curing: 3.76 ± 0.15%Vertex Castavaria: 3.91 ± 0.05%Vertex Castapress: 3.22 ± 0.06%	Residual monomer:<4.5%	Residual monomer:4.0%
Standards ofConformity	ISO 1567ISO 20795ISO 179-1ISO 7405ASTM F 895-84	ISO 1567	ISO 1567

Summary of Technical Characteristics

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Submitter:Vertex Dental B.V.	Vertex cold-curing denture base materialPremarket Notification: Traditional 510(k)
SubstantialEquivalence	The Vertex cold-curing denture base materials are substantiallyequivalent to the Probase Cold (K913655) and Major Repair (K082153),with respect to mode of action and intended use. It is substantiallyequivalent to the Probase Cold (K913655) and Major Repair (K082153)denture base materials, with respect to material of composition. Thesubmitted devices pose the same types of questions about safety oreffectiveness as the existing device.
Conclusion	The information discussed above demonstrates that the Vertex cold-curing denture base materials are substantially equivalent to thepredicate devices.
Declarations	• This summary includes only information that is also covered in thebody of the 510(k).• This summary does not contain any puffery or unsubstantiatedlabeling claims.• This summary does not contain any raw data, i.e., contains onlysummary data.• This summary does not contain any trade secret or confidentialcommercial information.• This summary does not contain any patient identification information.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 F. Greenrose Qserve America 220 River Road Claremont, New Hampshire 03743

MAR 2 5 2011

Re: K102640 Trade/Device Name: Vertex Self Curing Vertex Castavaria

Vertex Castapress Regulation Number: 21 CFR 872.3760

Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 22, 2011 Received: March 23, 2011

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 2- 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D.m

Anthony D. Watson, B.S., M.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

.102640

510(k) Number (if known):

Device Name:

Vertex Self Curing Vertex Castavaria Vertex Castapress

Indications For Use:

Vertex cold-curing denture base materials are indicated for:

Manufacture of full and partial dentures 1.
Repair of full and partial dentures 2.
ડે. Rebasing of full and partial dentures
1. Relining of full and partial dentures

Prescription Use (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 Puan

(Division Sign-Off)
Divisitation Sign-Off)
Divisites of Sentrol, Dental Devices Infection Cor

510(k) Number:

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.