Who is the manufacturer of VERTEX RAPID SIMPLIFIED?

Vertex-Dental B.V. filed the 510(k) submission for VERTEX RAPID SIMPLIFIED (K102654).

What is the FDA product code for VERTEX RAPID SIMPLIFIED?

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 RAPID SIMPLIFIED?

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

Who can help prepare an FDA 510(k) submission like VERTEX RAPID SIMPLIFIED?

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 RAPID SIMPLIFIED

Q: What are the predicate devices for VERTEX RAPID SIMPLIFIED?

Probase Hot (K913655); Major.Base 20 (K081884).

K102654 · Vertex-Dental B.V. · EBI · Dec 3, 2010 · Dental

Device Facts

Record ID	K102654
Device Name	VERTEX RAPID SIMPLIFIED
Applicant	Vertex-Dental B.V.
Product Code	EBI · Dental
Decision Date	Dec 3, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Vertex Rapid Simplified is indicated for: 1. Fabrication of full dentures 2. Fabrication of partial dentures

Device Story

Vertex Rapid Simplified is a conventional dough-pack, heat-cured denture base material. It consists of polymethyl methacrylate (PMMA) powder and a methyl methacrylate (MMA) monomer liquid. The material is processed using a pressing technique with a rapid 20-minute polymerization cycle (or overnight). Available in 10 shades. Used by dental professionals in a laboratory setting to fabricate full and partial dentures. The final cured acrylic provides the structural base for dental prostheses, benefiting patients by restoring oral function and aesthetics.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 1567, ISO 20795, ISO 179-1, ISO 7405, and ASTM F 895-84. Key physical properties reported: Charpy impact strength (11.3 kj/m²), flexural strength (85 MPa), flexural modulus (2367 MPa), water absorption (22.5 µg/mm³), water solubility (0.11 µg/mm³), and residual monomer (1.33 ± 0.16%).

Technological Characteristics

Denture base polymer; PMMA powder and MMA liquid. Components: PMMA, benzoyl peroxide, pigments (powder); MMA, ethyleneglycol dimethacrylate, N,N-dimethyl-4-toluidine, Tinuvin P (liquid). Heat-cured via pressing technique. Standards: ISO 1567, ISO 20795, ISO 179-1, ISO 7405, ASTM F 895-84. Cadmium-free.

Indications for Use

Indicated for fabrication 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 Hot (K913655)
Major.Base 20 (K081884)

Related Devices

K102640 — VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS · Vertex-Dental B.V. · Mar 25, 2011
K970522 — MYERSON'S ECONOMY DENTURE BASE MATERIAL · Austenal, Inc. · May 14, 1997
K123220 — VERTEX THERMOSENS RIGID · Vertex-Dental B.V. · Mar 1, 2013
K130076 — PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS · Merz Dental GmbH · Aug 22, 2013
K131036 — YAMAHACHI DENTURE BASE RESINS · Yamahachi Dental Manufacturing Co. · Jul 12, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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, rebasing 872.3760 EBI | | Predicate Devices: | Probase Hot (K913655), Major.Base 20 (K081884) | | Device Description and Statement of Intended 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 : - - - - - - - - - : : · ・ ت 100 million and ・ . 1994 .. : . {1}------------------------------------------------ | Submitter: Vertex Dental B.V. | Vertex hot-curing denture base material Premarket Notification: Traditional 510(k) | Feature | Vertex hot-curing denture base material | Probase Hot | Major.Base 20 | | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Summary of Technological Characteristics | All of the components found in Vertex™ hot-curing denture base materials have been used in leqally marketed devices and were found safe for dental use. | 510(k) Number | Not yet assigned | K913655 | K081884 | | | Substantial Equivalence | The Vertex hot-curing denture base material is substantially equivalent to the Probase Hot (K913655) and Major Base 20 (K081884), with respect to mode of action and intended use. It is substantially equivalent to the Probase Cold (K913655) and Major.Base 20 (K081884) denture base materials, with respect to material of composition. The submitted device pose the same types of questions about safety or effectiveness as 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 predicate devices. | | Classification # & Product Code | 872.3760 EBI | 872.3760 EBI | 872.3760 EBI | | Declarations | This summary includes only information that is also covered in the 0 body of the 510(k). This summary does not contain any puffery or unsubstantiated 0 labeling claims. This summary does not contain any raw data, i.e., contains only 0 summary data. This summary does not contain any trade secret or confidential 0 commercial·information. This summary does not contain any patient identification information. ০ | Indications for Use | The Vertex Rapid Simplified is indicated for: 3. Fabrication of full dentures 4. Fabrication of partial dentures | Partial and combination dentures, conventional or implant supported Complete dentures Hybrid dentures Relines of conventional or implant dentures | Major.Base 20 is a denture base polymer for dental prosthesis. Poly- methylmethacrylate based. Heat-processed polymer. Powder and liquid. It is used for: Dental prosthesis Partial prosthesis Clasp prosthesis | | | Composition of Materials | Powder: Polymethyl methacrylate, Benzoyl peroxide, Pigments Liquid: Methyl methacrylate, Ethyleneglycol dimethacrylate, N,N- dimethyl-4-toluidine, Tinuvin P | Powder: Polymethyl methacrylate, softening agent, benzoyl peroxide, pigments Liquid: Methyl methacrylate, dimethacrylate (linking agent), catalyst | Powder: Poly-methylmethacrylate, Pigments Liquid: Methyl methacrylate, Ethyleneglycol dimethacrylate, N,N- dimethyl-p-toluidine, Benzophenone-3 | | | | | Physical Properties | Charpy impact strength: 11.3 kj/m² flexural strength: 85 MPa flexural modulus: 2367 MPa water absorption: 22.5 µg/mm³ water solubility: 0.11 µg/mm³ Residual monomer: 1.33 ± 0.16% | Charpy impact strength: 1.36 kj/m²± 0.09 flexural strength 87.4 ± 8.9 (MPa) flexural modulus 2904.9 ± 281.4 (MPa) Residual monomer: <2.2% | Charpy impact strength: 1.36 kj/m²±0.03 flexural strength: 78 MPa flexural modulus: 2390 MPa water absorption: 22.0 µg/mm³ water solubility: 1.5 µg/mm³ Residual monomer: 1.8% | | | | | Standards of Conformity | ISO 1567 ISO 20795 ISO 179-1 ISO 7405 ASTM F 895-84 | ISO 1567 | ISO 1567 | | | | Section 5.0: 510(k) Summary . . . . and the comments of the comments of the comments of the comments of {2}------------------------------------------------ ### Submitter: Vertex Dental B.V. ## Summary of Technical Characteristics : . Section 5.0: 510(k) Summary ・・ · · . . " . : ・ · {3}------------------------------------------------ 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. {4}------------------------------------------------ #### 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 {5}------------------------------------------------ ## 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 2. 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