YAMAHACHI DENTURE BASE RESINS

{0}------------------------------------------------ # 510(k) Summary # 510(k) Owner JUL 1 2 2013 Yamahachi Dental Manufacturing Co. 54-1 Ochigara, Nishiura-Cho Gamagori City, Aichi Pref., Japan 443-0105 | Phone: | 081-533-577121 | |----------|-------------------------------------------| | Fax: | 081-533-5771764 | | Contact: | Lawrence Greenwald (yamahachi1@yahoo.com) | ## Date Prepared April 1, 2013 ## Consultant Denterprise International, Inc. 110 E. Granada Blvd., Suite 207 Ormond Beach, FL 32176 | Phone: | 386-672-0450 | |--------------------|-----------------------------------------------------------------------------------------------| | Fax: | 386-672-4402 | | Primary Contact: | Claude Berthoin, President (claude@510kfda.com) | | Secondary Contact: | John Gillespy, VP Regulatory Affairs (john@510kfda)<br>Holly Layne, Assistant (holly@510kfda) | ## Device Classification | 510(k) Name: | Yamahachi Denture Base Resins | |----------------------|--------------------------------------------------------------| | Trade/Model Names: | Basis, Basis HI, Basis Twin Cure, Basis Flow, Re-Fine Bright | | Common Name: | Denture Base Polymer | | Classification Name: | Denture Relining, Repairing, or Rebasing Resin | | Regulation Number: | 872.3760 | | Product Code: | EBI | | Regulatory Class: | II | # Predicates | K102874 | Veracril, Veracril HI, Ez-Cryl (New Stetic, Columbia) | |---------|------------------------------------------------------------------------| | K102640 | Vertex Self-Curing, Vertex Castavaria (Vertex Dental, The Netherlands) | {1}------------------------------------------------ #### Intended Use Yamahachi Denture Base Resins is a system of heat- and self-cure acrylic polymers intended for fabrication or repair of the denture base. #### Device Description Yamahachi Denture Base Resins is supplied in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) beads with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator. To fabricate the denture base, the powder and liquid materials are mixed together and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures either through heat application (water bath, rapid immersion, or microwave oven) or a self-curing process (pressure vessel or via quick-setting). While heat-cure resins are generally used to fabricate denture bases, self-cure acrylics are most often indicated for repair and relining of the dentures. The subject device includes three heat-cure resins (Basis, Basis HI, and Basis Twin Cure) and two self-cure resins (Basis Flow and Re-Fine Bright). #### Device Comparison To Predicates A comparison of technological characteristics between the subject and predicate devices follows in Tables 5A and 5B ... # Table 5A -- Comparison Of Heat-Cure Acrylics | | Subject Devices | Predicate Devices | Differences | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Names | Basis, Basis HI,<br>Basis Twin Cure | Veracril, Veracril HI,<br>EZ-cryl | NA | | Manufacturer | Yamahachi Dental (Japan) | New Stetic (Columbia) | NA | | 510(k) | Not assigned yet | K102874 (Bundle of 5 Heat-Curing<br>& 3 Self-Curing) | NA | | Classification &<br>Product Code | 872.3760; EBI | 872.3760; EBI | NA | | Device Description | Traditional heat-cure &<br>microwave-cure acrylic<br>resin for total or partial<br>denture base and for<br>removable prosthesis | Denture system consisting of<br>monomer and polymer powder and<br>liquid components (traditional<br>heat-cured & microwave-cured<br>acrylic resin for total or partial<br>denture base and for removable<br>prosthesis) | No difference in<br>Device Description or<br>Intended Use | | Intended Use | Repair or fabrication of denture base | Repair or fabrication of denture base | | | Product State | Polymer powder &<br>monomer liquid | Polymer powder & monomer liquid | | | Mixing Ratio<br>(Powder:Liquid) | 100g:43ml (Basis & Basis<br>HI); 100g:40ml (Basis Twin<br>Cure) | 2:1 by weight or 3:1 by volume | The only difference in | | Mixing Time | 30 sec | 30 sec | Method Of Use is | | Pressing Technique | Pack dough in plaster<br>model, apply pressure, trim<br>excess, apply final pressure<br>(10 - 15 minute packing<br>time) | Pack dough in flask, apply pressure,<br>trim excess, apply final pressure | determination of<br>mixing ratio. This<br>difference is related to<br>characteristics of<br>polymer particle size,<br>but does not affect | | Application Time | 30 minutes | Approx 10 minutes | | | Polymerization<br>(Curing) Method | Water Bath: Immerse flask<br>in water & slowly raise to<br>boiling over 30 min, boil 30<br>- 40 min, air cool 30 min<br>(Basis & Basis HI); Rapid<br>Curing: Immerse flask in<br>boiling water 30 min (Basis<br>TC); Microwave: Put flask<br>in MWO 500W for 3 min,<br>air cool 30 min (Basis TC) | Water Bath: 90 min at 73° C, 30<br>min boiling, 30 min air cool, 15 min<br>water cool (Veracril devices);<br>Microwave: 10 min in 3 stages in<br>MWO, air cool 30 min, 15 min<br>water cool (EZ-cryl only) | performance of device<br>nor raise issues of<br>safety or effectiveness,<br>a conclusion<br>supported by meeting<br>requirements of<br>standard ISO 20795-1. | | Components (See<br>legend after table) | Powder: PMMA, MMA<br>(Basis Hi), initiator,<br>pigments;<br>Liquid: MMA, crosslinker,<br>activator (Basis TC) | Powder: PMMA, pigments;<br>Liquid: MMA, crosslinker | The only difference in<br>Product Components<br>are minor variances in<br>percentages of<br>ingredients, which do<br>not affect product<br>performance, safety,<br>or effectiveness, as<br>supported by meeting<br>the standards of ISO<br>20795-1. | | Standards of<br>Conformity | ISP 9001:2008; ISO<br>13485:2003; MDD<br>(93/42/EEC); ISO 14971 | ISP 9001:2008; ISO 13485:2003 | | | Biocompatibility | ISO 10993-1, ISO 7405 | ISO 10993-1, ISO 7405 | | | Physical Properties | ISO 20795-1 | ANSI/ADA 12:2002; ISO 1567:1999 | | | Flexural Strength<br>(65 MPa Minimum) | Basis: 84.3 MPa;<br>Basis HI: 87 MPa;<br>Basis Twin Cure: 81.0 MPa | Veracril: 70.8 MPa;<br>Veracril HI: 88.1 MPa;<br>Ez-cryl: 70.5 MPa | All Physical Properties<br>within specification | | Flexural Modulus<br>(2,000 MPa Min) | Basis: 2,067 MPa;<br>Basis HI: 2,178 MPa;<br>Basis Twin Cure: 2,299 MPa | Veracril: 5,300 MPa;<br>Veracril HI: 5,804 MPa;<br>Ez-cryl: 5,700 MPa | | | Impact-Resistance<br>(Min 1.9 MPa m1/2) | Basis/Basis TC: Not<br>Applicable;<br>Basis HI: ><br>$2.26 MPa m^{1/2}$ | Veracril/Ez-cryl: Not Applicable;<br>Veracril High Impact: $3.1 MPa m^{1/2}$ | | | Residual Monomer<br>(Maximum 2.2%) | Basis: 0.4%;<br>Basis HI: 0.7%;<br>Basis Twin Cure: 0.2% | Veracril: 0.98%;<br>Veracril HI: 1.88%;<br>Ez-cryl: 0.80% | | | Sorption<br>(Max 32 ug/mm3) | Basis: 10.7 ug/mm3;<br>Basis HI: 22.8 ug/mm3;<br>Basis Twin Cure: 22.4 ug/mm3 | Veracril: 18.1 ug/mm3;<br>Veracril Hi: 14.5 ug/mm3;<br>Ez-cryl: 19.1 ug/mm3 | | | Solubility<br>(Max 1.6 ug/mm3) | Basis: 0.6 ug/mm3;<br>Basis HI: 0.4 ug/mm3;<br>Basis Twin Cure: 0.2 ug/mm3 | Veracril: 0.8 ug/mm3;<br>Veracril HI: 0.9 ug/mm3;<br>Ez-cryl: 0.72 ug/mm3 | | | Classification<br>(ISO 20795-1:2008) | Basis & Basis HI: Type 1 Class 1;<br>Basis Twin Cure: Type 5 | Veracril & Veracril HI: Type 1 Class 1;<br>EZ-cryl: Type 5 | No Classification<br>difference | {2}------------------------------------------------ ・ . {3}------------------------------------------------ MMA - Methyl-methacrylate PMMA - Poly-methyl-methacrylate PEMA - 2-(N-pyrolyl) ethyl methacrylate # Table 5B -- Comparison Of Self-Cure Acrylics | | Subject Devices | Predicate Devices | Differences | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Device Names | Basis Flow,<br>Re-Fine Bright | Vertex Self Curing,<br>Vertex Castavaria | NA | | Manufacturer | Yamahachi Dental (Japan) | Vertex-Dental (Netherlands) | NA | | 510(k) | Not assigned yet | K102640 (Bundle of 3 Self-<br>Curing Resins) | NA | | Classification &<br>Product Code | 872.3760; EBI | 872.3760; EBI | | | Device Description | Basis Flow: Self-curing<br>denture base material<br>intended as a pouring and<br>repair acrylic.<br>Re-fine Bright: Multifunctional<br>self-polymerizing denture<br>base material for repair and<br>relining of full & partial<br>dentures | Vertex Self Curing: Self-curing<br>denture base material<br>intended as a pouring and<br>repair acrylic.<br>Vertex Castavaria:<br>Multifunctional self-<br>polymerizing denture base<br>material for repair and<br>relining of full & partial<br>dentures | No difference in Device<br>Description or Intended<br>Use | | Intended Use | Repair and relining of full &<br>partial dentures | Fabrication, repair and<br>relining of full & partial<br>dentures | | {4}------------------------------------------------ | Product State | Polymer powder & monomer<br>liquid | Polymer powder & monomer<br>liquid | The only difference in<br>Method Of Use is<br>curing method for Re-<br>Fine Bright, which is not<br>pressure cured. This<br>difference does not<br>affect performance of<br>device, safety, or<br>effectiveness, as<br>supported by meeting<br>requirements of<br>standard ISO 20795-1. | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Mixing Ratio<br>(Powder:Liquid) | 100 g : 50 - 60 ml | 100 g : 60 ml | | | Mixing Time | 5 - 30 sec | 20 sec | | | Dough Time | Max 3 min | Max 4.5 - 8 min | | | Working Time | Max 4 min | Max 5 - 8 min | | | Polymerization<br>(Curing) Method | Basis Flow: 30 min at 55° C in<br>0.2 atm pressure vessel, air<br>cool 30 min;<br>Re-Fine Bright: Let hard<br>polymerize | Vertex Self Curing: 10 min at<br>55° C in 2.5 bar pressure<br>vessel;<br>Vertex Castavaria: 30 min at<br>55° C in 2.5 bar pressure<br>vessel | | | Components (See<br>legend before<br>table) | Powder: PMMA, PEMA,<br>activators, pigments;<br>Liquid (Basis Flow): MMA,<br>crosslinker, activator;<br>Liquid (Re-fine Bright): MMA,<br>crosslinker, activators | Powder: PMMA 99.1%,<br>Inhibitor (dibenzoyl peroxide)<br><1%;<br>Liquid: MMA >95%,<br>Crosslinker <5%, Accelerators<br><1%, UV Absorber << 1% | The only difference in<br>Product Components<br>are minor variances in<br>percentages of<br>ingredients, which do<br>not affect product<br>performance, safety, or<br>effectiveness, as<br>supported by meeting<br>the standards of ISO<br>20795-1. | | Standards of<br>Conformity | ISP 9001:2008; ISO<br>13485:2003; MDD<br>(93/42/EEC); ISO 14971 | ISO 1567, ISO 179-1, ASTIM F<br>895-84 | | | Biocompatibility | ISO 10993-1, ISO 7405 | ISO 7405 | | | Physical Properties | ISO 20795-1 | ISO 20795-1 | | | Flexural Strength<br>(60 MPa Minimum) | Basis Flow: 80.1 MPa;<br>Re-Fine Bright: 73.8 MPa | Vertex Self Curing: 68 MPa;<br>Vertex Castavaria: 79MPa | | | Flexural Modulus<br>(1,500 MPa Min) | Basis Flow: 1,657 MPa;<br>Re-Fine Bright: 1,529 MPa | Vertex Self Curing: 2,028 MPa;<br>Vertex Castavaria: 2,316 MPa | All Physical Properties<br>within specification | | Residual Monomer<br>(Maximum 4.5%) | Basis Flow: 4.2%;<br>Re-Fine Bright: 3.3% | Vertex Self Curing: 3.76%;<br>Vertex Castavaria: 3.91% | | | Sorption<br>(Max 32 ug/mm3) | Basis Flow: 18.8 ug/mm3;<br>Re-Fine Bright: 15.8 ug/mm3 | Vertex Self Cure: 20.3 ug/mm3; Vertex<br>Castavaria: 23.2 ug/mm3 | | | Solubility<br>(Max 8.0 ug/mm3) | Basis Flow: 1.8 ug/mm3;<br>Re-Fine Bright: 2.3 ug/mm3 | Vertex Self Cure: 1.8 ug/mm3;<br>Vertex Castavaria: 1.8 ug/mm3 | | | Classification<br>(ISO 20795-1:2008) | Basis Flow: Type 2 Class 2;<br>Re-Fine Bright: Type 2 Class 1 | Vertex SC: Type 2 Class 2;<br>Vertex Castavaria: Type 2<br>Class 1 | No Classification<br>difference | {5}------------------------------------------------ ## Non-Clinical Tests Bench tests were performed on the subject device in conformity with ISO 20795-1. These tests confirmed the different resins (Basis, Basis Twin Cure, Basis Flow, and Re-Fine Bright) all met the performance criteria established by that standard. ### Substantial Equivalence Discussion As noted above ... - Product Description and Intended Use are the same for the subject and predicate . devices. - . The only difference in Method Of Use is determination of mixing ratio. This difference is related to characteristics of polymer particle size, but does not affect performance of device nor raise issues of safety or effectiveness, a conclusion supported by meeting requirements of standard ISO 20795-1. - The only difference in Product Components are minor variances in percentages of . ingredients, which do not affect product performance, safety, or effectiveness, as supported by meeting the standards of ISO 20795-1. - . The Physical Properties of both the subject and predicate devices conform to the standards of ISO 20795-1. - Classification of the dental acrylic resins is the same between subject and predicate . devices. Yamahachi Denture Base Resins has the same intended use as the predicates. The subject device also has minor differences in technological characteristics that could not affect safety or effectiveness. Bench tests show conformance with performance standards in ISO 20795-1:2008 for all five models included in this submission (Basis, Basis HI, Basis Twin Cure, Basis Flow, and Re-fine Bright). In conclusion, Yamahachi Denture Base Resins warrants a finding of substantial equivalence to legally marketed devices from New Stetic (Columbia) and Vertex Dental (The Netherlands) and of proper clearance for premarketing activities in the United States. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing segments and three wave-like lines below, possibly representing water or movement. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 12, 2013 Yamahachi Dental Manufacturing Co. C/O Mr. Claude Berthoin, President Denterprise International, Inc. 110 E. Granada Boulevard, Suite 207 Ormond Beach, FL 32176 Re: K131036 Trade/Device Name: Yamahachi Denture Base Resins Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Repairing Resin Regulatory Class: II Product Code: EBI Dated: April 26, 2013 Received: April 29, 2013 Dear Mr. Berthoin: 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. {7}------------------------------------------------ Page 2 - Mr. Berthoin 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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/7/Picture/6 description: The image shows the text "Mary S. Runner -S". The text is written in a clear, bold font, making it easily readable. The letters are black, contrasting with the white background. Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications For Use Statement Applicant: Yamahachi Dental Manufacturing Co. | 510(k) Number (if known): | K131636 | |---------------------------|---------| |---------------------------|---------| Device Name: Yamahachi Denture Base Resins Indications For Use: Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base. All devices are sold by or on the order of a physician. They are not for use by the general public or over-the-counter. Prescription Use _X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use _ (21 CFR Part 801 Subpart C) (Please Do Not Write Below This Line - Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE). Division Sign-Off Office of Device Evaluation 510(k) (Division Sign-Off) (Division Sign-Off) Division of Anesthealogy, General Hospital Division of Antost Dental Devices 510(k) Number: k131036