Who is the manufacturer of VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

Vertex-Dental B.V. filed the 510(k) submission for VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS (K102640).

What is the FDA product code for VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS

Q: What are the predicate devices for VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS?

Probase Cold (K913655); Major Repair (K082153).

K102640 · Vertex-Dental B.V. · EBI · Mar 25, 2011 · Dental

Device Facts

Record ID	K102640
Device Name	VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
Applicant	Vertex-Dental B.V.
Product Code	EBI · Dental
Decision Date	Mar 25, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3760
Device Class	Class 2

Intended Use

Vertex cold-curing denture base materials are indicated for: 1. Manufacture of full and partial dentures 2. Repair of full and partial dentures 3. Rebasing of full and partial dentures 4. Relining of full and partial dentures

Device Story

Vertex cold-curing denture base materials (Self Curing, Castavaria, Castapress) are self-polymerizing acrylic resins composed of polymethyl methacrylate powder and methyl methacrylate liquid. Used by dental professionals in clinical or laboratory settings to fabricate, repair, rebase, or reline full and partial dentures. Vertex Self Curing polymerizes in 10 minutes using a pressure vessel; Castavaria is a pourable, multifunctional material with minimized shrinkage and extended working time; Castapress is a pouring/casting material featuring a unique accelerator system for color stability. The materials are shaded to simulate gum tissue using cadmium-free pigments. The final cured acrylic provides the structural base for dental prostheses, restoring function and aesthetics for patients.

Clinical Evidence

Bench testing only. Performance data provided includes flexural strength, flexural modulus, water absorption, water solubility, and residual monomer content. Results demonstrate compliance with ISO 1567, ISO 20795, ISO 179-1, ISO 7405, and ASTM F 895-84 standards.

Technological Characteristics

Polymethyl methacrylate powder and methyl methacrylate liquid. Cadmium-free pigments. Self-polymerizing (cold-curing) acrylic resin. Standards: ISO 1567, ISO 20795, ISO 179-1, ISO 7405, ASTM F 895-84. No software or electronic components.

Indications for Use

Indicated for the manufacture, repair, rebasing, and relining of full and partial dentures in patients requiring dental prosthetics.

Regulatory Classification

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.

Predicate Devices

Probase Cold (K913655)
Major Repair (K082153)

Related Devices

K102654 — VERTEX RAPID SIMPLIFIED · Vertex-Dental B.V. · Dec 3, 2010
K131036 — YAMAHACHI DENTURE BASE RESINS · Yamahachi Dental Manufacturing Co. · Jul 12, 2013
K082700 — TEMPORARY COLD.V AND SELF-CURE DENTINE · Major Prodotti Dentari S.P.A. · Dec 9, 2008
K990763 — VITRON M · Espe Dental AG · May 25, 1999
K972573 — LIQCRYLIC PRO DENTAL RESIN · Dentsply Intl. · Sep 16, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ K102640v Submitter: Vertex Dental B.V. Vertex cold-curing denture base material Premarket Notification: Traditional 510(k) MAR 2 5 2011 . ー | 510(k) Summary | |----------------| | Submitter Name: Submitter Address: | Vertex Dental B.V. Johan van Oldenbarneveltlaan 62, 3705 HJ Zeist The Netherlands | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone Number: Fax Number: | 31 30 69 767 49 31 30 69 551 88 | | Contact Person: Contact Address: | William Greenrose 220 River Rd. Claremont, NH 03743 | | Phone Number: Fax Number: | 603-369-3550 603-369-3562 | | 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, rebasing 872.3760 EBI | | Predicate Devices: | Probase Cold (K913655), Major Repair (K082153) | | Device Description and Statement of Intended 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 | {1}------------------------------------------------ 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 - 2. 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. 0 {2}------------------------------------------------ | Feature | Vertex Cold-Curing Denture base material | Probase Cold | Major Repair | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Not yet assigned | K913655 | K082153 | | Manufacturer | Vertex Dental B.V. | Ivoclar | Major Prodotti Dentari S.p.a | | Classification # & Product Code | 872.3760 EBI | 872.3760 EBI | 872.3760 EBI | | Indications for Use | Vertex cold-curing denture base materials are indicated for: 1. Manufacture of full and partial dentures 2. Repair of full and partial dentures 3. Rebasing of full and partial dentures 4. Relining of full and partial dentures | The cold-curing ProBase Cold is suitable for both the pouring and the packing technique. Indication - Partial dentures - Combination dentures - Relining - Repairs - Complete dentures | Major.Repair is a cold- curing polymer for dental prosthesis. Poly- methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid. It is used to: - repair and rebase prosthesis - temporary prosthesis | | Physical Properties | flexural strength: Vertex Self Curing: 68 MPa Vertex Castavaria: 79 MPa Vertex Castapress: 75 MPa | flexural strength: 63.44 ± 4.24 MPa | flexural strength: 66.4 MPa | | | flexural modulus: Vertex Self Curing: 2028 MPa Vertex Castavaria: 2316 MPa Vertex Castapress: 2293 MPa | flexural modulus: 1832.00 ± 88.87 MPa | flexural modulus: 2217 MPa | | | water absorption: Vertex Self Curing: 20.3 µg/mm³ Vertex Castavaria: 23.2 µg/mm³ Vertex Castapress: 22.1 µg/mm³ | | water absorption: 21.2 µg/mm³ | | | Water solubility: Vertex Self Curing:1.8 µg / mm³ Vertex Castavaria: 1.8 µg / mm³ Vertex Castapress:1.19 ± 0.18 µg / 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 of Conformity | ISO 1567 ISO 20795 ISO 179-1 ISO 7405 ASTM F 895-84 | ISO 1567 | ISO 1567 | ## Summary of Technical Characteristics {3}------------------------------------------------ | Submitter: Vertex Dental B.V. | Vertex cold-curing denture base material Premarket Notification: Traditional 510(k) | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence | The Vertex cold-curing denture base materials are substantially equivalent to the Probase Cold (K913655) and Major Repair (K082153), with respect to mode of action and intended use. It is substantially equivalent to the Probase Cold (K913655) and Major Repair (K082153) denture base materials, with respect to material of composition. The submitted devices pose the same types of questions about safety or effectiveness as the existing device. | | Conclusion | The information discussed above demonstrates that the Vertex cold- curing denture base materials are substantially equivalent to the predicate devices. | | Declarations | • This summary includes only information that is also covered in the body of the 510(k). • This summary does not contain any puffery or unsubstantiated labeling claims. • This summary does not contain any raw data, i.e., contains only summary data. • This summary does not contain any trade secret or confidential commercial information. • This summary does not contain any patient identification information. | ・ . . : {4}------------------------------------------------ ## 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ ## 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 - 4. 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: