RMGI FILL

{0}------------------------------------------------ KVJo-223 MAR 2 9 2013 # PULPDENT CORPORATION 80 Oakland Street Watertown, MA 02472 USA Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com ## 510(k) SUMMARY DATE OF SUBMISSION: January 25, 2013 #### OWNER: Pulpdent Corporation #### CONTACT: Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: Fax: Email: 617-926-6666 617-926-6262 ken@pulpdent.com #### DEVICE: Trade Name: Pulpdent RMGI Fill Classification Name: Dental cement FDA Product Code: EMA, 21 CFR Part 872.3275 #### PREDICATE DEVICES: Pulpdent RMGI Low Viscosity - 3M ESPE Ketac Nano Glass Ionomer Restorative GC Fuji Filling LC #### INTENDED USE: Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation used by dental professionals as a restorative filling material. ## DESCRIPTION: Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation with both a bioactive resin matrix and bioactive glass fillers. In this context 'bioactive' refers to the release of beneficial ions from the resin and glass fillers into the oral environment. As a resin-modified glass ionomer, Pulpdent RMG/ Fill has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no BisGMA and no BPA derivatives. Pulpdent RMG/ Fill is a paste-paste formulation provided in an automix syringe that is used by dental professionals as filling material in dental restorations. #### SUMMARY OF PERFORMANCE TESTING - BENCH | Flexural strength | 102.0 MPa | |---------------------------------|-----------------------------------------------------| | Flexural modulus | 4.3 GPa | | Compressive strength | 280.0 MPa | | Diametral tensile strength | 42.0 MPa | | Light cure set time | 20 seconds | | Self-cure set time (intraoral) | 2 minutes, 20 seconds at 37°C | | Self-cure set time (extra-oral) | 3 minutes, 30 seconds from beginning of mix at 20°C | | Shear bond strength | 28 MPa (RMGI Fill to composite) | | Radiopacity | Equivalent to 2 mm aluminum | | Polymerization shrinkage | 1.7% | 1 / 5 {1}------------------------------------------------ # PULPDENT CORPORATION 80 Oakland Street Watertown, MA 02472 USA Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com # COMPARISON WITH PREDICATE PRODUCTS: Pulpdent RMGI Fill is substantially equivalent in design, composition, performance and intended use to the predicate products: | Product | Description | Intended Use | Composition | |---------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Pulpdent RMGI Fill | Resin-modified glass<br>ionomer in two pastes | Dental restorative | Part A: Diurethane dimethacrylate and other<br>methacrylate- based monomers and oligomers;<br>polyacrylic acid/maleic acid copolymer, water, barium<br>borosilicate glass, silica, reducing agents,<br>photoinitiator, colorants.<br><br>Part B: Diurethane dimethacrylate and other<br>methacrylate- based monomers and oligomers;<br>aluminoflurosilicate ionomer glass, silica, oxidizing<br>agents. | | Pulpdent<br>RMGI Low Viscosity<br>K123265 | Resin-modified glass<br>ionomer in two pastes | Dental liner, base or<br>luting agent. | Part A: Diurethane dimethacrylate and other<br>methacrylate- based monomers and oligomers,<br>polyacrylic acid/maleic acid copolymer, water, barium<br>borosilicate glass, silica, reducing agents,<br>photoinitiator.<br><br>Part B: Diurethane dimethacrylate and other<br>methacrylate- based monomers and oligomers,<br>aluminoflurosilicate ionomer glass, silica, oxidizing<br>agents. | | 3M Espe<br>Ketac Nano Glass<br>Ionomer Restorative<br>K052235 | Light cure, resin-<br>modified glass<br>ionomer in two pastes | Dental restorative | Part A: Silane-treated glass, zirconia and silica;<br>ionomer glass; BisGMA; PEGDMA; HEMA; TEGDMA.<br><br>Part B: Silane-treated ceramic; co-polymer of acrylic<br>and itaconic acids; HEMA; water. | | GC<br>Fuji Filling LC<br>K051427 | Light cure, resin-<br>modified glass<br>ionomer in two pastes | Dental restorative | Part A: Aluminoflurosilicate ionomer glass; urethane<br>dimethacrylate; HEMA.<br><br>Part B: Polyacrylic acid; water; amorphous, fumed<br>silica; urethane dimethacrylate. | {2}------------------------------------------------ 80 Oakland Street Watertown, MA 02472 USA Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com | | Compressive<br>Strength<br>MPa | Flexural Strength<br>MPa | Flexural Modulus<br>GPa | Diametral<br>Tensile strength<br>(DTS) MPa | |--------------------------------|--------------------------------|--------------------------|-------------------------|--------------------------------------------| | Pulpdent RMGI Fill | 280 | 102 | 4.3 | 42.0 | | Pulpdent RMGI<br>Low Viscosity | 239 | 88 | | 36 | | 3M ESPE<br>Ketac Nano | 236 | 35 | 5.4 | 32 | | GC<br>Fuji Filling LC | 165 | 28 | 12.3 | 15 | From the above comparisons and the bench testing, it can be concluded that Pulpdent RMG/ Fill is substantially equivalent in design, composition, performance and intended use to the products listed above. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3275 and have been used by dental professionals for more than 20 years. A search of the relevant scientific literature shows that resinmodified glass ionomers, used as a restorative filling material, have been extensively studied. See References below. #### REFERENCES Specific to Pulpdent RMGI Fill and RMGI Low Viscosity (K123265) - Pameijer CH, et al. Biocompatibility of four experimental formulations [including Pulpdent 1. RMGI Fill] in subcutaneous connective tissue of rats. Pulpdent Corporation. 2011 Nov. - 2. Pameijer CH. Report on the retention of Embrace WetBond cement and a RMGI cement (Pulpdent). Pulpdent Corporation 2012 Aug. - 3. Pameijer CH et al. Marginal leakage with RMGI filled restorations and castings cemented with a RMGI luting cement. University of El Salvador/Argentine Dental Association, Buenos Aires, Argentina. 2012 Jun. - 4. Pameijer CH. Microleakage of four experimental resin-modified glass ionomer restorative materials. Pulpdent Corporation. 2011 Apr. - ട്. Pameiier CH, Zmener O. Histopathological evaluation of RMGI cement, auto- and lightcured, used as a luting agent. A subhuman primate study. Pulpdent Corporation. March 2011. #### General - Booth SE. Surface properties and the bioactivity of glass-ionomer dental cements and દ. related materials. PhD Thesis, University of Greenwich. 2010. {3}------------------------------------------------ 80 Oakland Street Watertown, MA 02472 USA Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com - 7. Comisi JC. Using bioactive materials to achieve proactive dental care. Oral Health. 2011 Dec. Dec;34-46. - 8. Dülgergil CT. et al. Atraumatic restorative treatment with resin-modified glass ionomer material: short term results of a pilot study. Med Princ Pract. 2005 Jul-Aug;14(4):277-80. - Daou MH, et al. Clinical evaluation of four different dental restorative materials. one year റു. results. Schweiz Monatsschr Zahnmed. 2008;118(4):290-5. - 10. Donly KJ, et al. Clinical performance and caries inhibition of resin-modified glass ionomer cement and amalgam restorations. J Am Dent Assoc. 1999 Oct;130(10):1459-66. - 11. Ermis RB. Two-vear clinical evaluation of four polyacid-modified resin composites and a resin-modified glass-ionomer cement in Class V restorations. Quintessence Int. 2002 Jul-Aug;33(7):542-8. - 12. Gandolfo MG. et al. Biomimetic Remineralization of human dentin using promising innovative calcium silicate hybrid "smart" materials. Dent Mater. 2011 Nov:27(11):1055-69. - 13. Goldstep F. Proactive intervention dentistry: a model for oral care through life. Compend Contin Educ Dent. 2012 Jun;33(6):394-6, 398-402; quiz 404, 416. - Gomes SC, et al. Clinical and histologic evaluation of the periodontal response to 14. restorative procedures in the dog. Int J Periodontics Restorative Dent. 2005 Feb;25(1):39-47. - Hübel S. Meiàre I. Conventional versus resin-modified glass-ionomer cement for Class II 15. restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8. - 16. Kotsanos N. Arizos S. Evaluation of a resin modified glass ionomer serving both as indirect pulp therapy and as restorative material for primary molars. Eur Arch Paediatr Dent. 2011 Jun;12(3):170-5. - 17. Loof J et al. A comparative study of the bioactivity of three materials for dental applications. Dent Mater. 2008 May;24(5):653-9. Epub 2007 Aug 28. - 18. Loguercio AD, et al. Five-year double-blind randomized clinical evaluation of a resinmodifed glass ionomer and a polyacid-modified resin in non-carious cervical lesions. J Adhes Dent. 2003 Winter;5(4):323-32. - Matsuya S, et al. Structure of bioactive glass and its application to glass ionomer cement. 19. Dent Mater J. 1999 Jun;18(2):155-66. - 20. Mitra SB, et al. Fluoride release and recharge behavior of a nano-filled resin-modified glass ionomer compared with that of other fluoride releasing materials. Am J Dent. 2011 Dec;24(6):372-8. - 21. Mousavinasab SM, et al. Flexural strength and morphological characteristics of resinmodified glass-ionomer containing bioactive glass. J Contemp Dent Pract. 2011 Jan 1;12(1):41-6. - Murray PE, et al. Restorative pulpal and repair responses. JADA 2001 Apr,132:482-91. 22. {4}------------------------------------------------ ## PULPDENT CORPORATION 80 Oakland Street Watertown, MA 02472 USA Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com - Nicholson JW, Czarnecka B. The biocompatibility of resin-modified glass-ionomer cements 23. for dentistry. Dent Mater. 2008 Dec;24(12):1702-8. : - Pereira AF, et al. Influence of restorative techniques on marginal adaptation and dye 24. penetration around Class V restorations. Gen Dent. 2012 Jan-Feb;60(1):e17-21. - Roberts HW, et al. Hardness of three resin-modified glass-ionomer restorative materials as 25. a function of depth and time. J Esthet Restor Dent. 2009;21(4);262-72. - 26. Salata LA et al. Recent advances in the use of glass ionomers: bone substitutes. Rev Odontol Univ Sao Paulo. 1999 Apr/June;13(2):203-7. - Sampaio PC, et al. Effect of conventional and resin-modified glass-ionomer liner on dentin 27. adhesive interface of Class I cavity walls after thermocycling. Oper Dent. Jul-Aug;36(4):403-12. - 28. Stanley HR. Local and systemic responses to dental composites and glass ionomers. Adv Dent Res. 1992 Sep:6:55-64. - 29. Tarim B. et al. Pulpal response to a resin-modified glass-ionomer material on non-exposed and exposed monkey pulps. Quintessence Int. 1998 Aug;29(8):535-42. - 30. Yli-Urpo H, et al. Compound changes and tooth mineralization effects of glass ionomer cements containing bioactive glass (S53P4), an in vivo study. Biomaterials. 2005 Oct;26(30):5934-41. - 31. Zhou SL, et al. In vitro study of the effects of fluoride-releasing dental materials on Remineralization in an enamel erosion model. J Dent. 2012 Mar;40(3):255-63. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 29, 2013 Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street PO Box 780 WATERTOWN MA 02472 USA Re: K130223 Trade/Device Name: Pulpdent RMGI FILL Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 25, 2013 Received: February 6, 2013 Dear Mr. Berk: 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. {6}------------------------------------------------ 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 (OS) 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, Kwame O. Ulmer -S for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Pulpdent RMGI FILL Indications for Use: Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation used by dental professionals as filling material in dental restorations. 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) ~ --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ・・・・・・・・ Andrew l. Steen [ _ Steen ] _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices Page 1 of 1 .. K130223 510(k) Number: . - - . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・・・・・・・ : 2-1