Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 3, 2017 SwissMediTec GmbH Kurosh Sohi Senior Director/ OA Gfellen 26 Finsterwald. 6162 Luzern SWITZERLAND Re: K170873 Trade/Device Name: Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 21, 2017 Received: August 2, 2017 Dear Kurosh Sohi: This letter corrects our substantially equivalent letter of October 2, 2017. 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. Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure. {1}------------------------------------------------ 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 (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 contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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, Image /page/1/Picture/9 description: The image shows the name "Mary S. Runner -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are uniformly sized and spaced, contributing to the legibility of the name. for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K170873 #### Device Name Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl Indications for Use (Describe) - 1) Direct anterior and posterior restorations (including occlusal surfaces) - 2) Direct veneers - 3) Correction of tooth position and tooth shape - 4) Indirect restorations including inlays, onlays and veneers - 5) Intraoral repairs of fractured restorations - 6) Core build-ups - 7) Splinting | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 5.1 Device Description The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are visible light-cure, radiopaque restorative material (Composite) with high polishingability, excellent physical properties and are designed for anterior and posterior restorations. The subject devices formulated from multifunctional methacrylate monomer-based resin, photo initiator, silanated inorganic filler and pigments. Available in multiple shades. These restoratives provides high strength and low wear for durability. They are packaged in traditional syringes and Pre-Loaded Tips. ### (a) Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth. They are classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF) according to CFR-872. ### (b) Classification. Class II. Physical and mechanical properties of the subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) are evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative materials). According to ISO 4049: 2009, the subject devices are classified into the following: - Type II: Polymer-based restorative materials; - Class 2: materials whose setting is effected by light; - Group I: materials whose use requires the energy to be applied intra-orally. ## Section 5.2 Indication for Use Statement The Indication for Use of the subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter.Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) were prepared based on that of the predicate device. Therefore, the intended purposes of the subject devices are substantially equivalent to those of the predicate device (Clearfil Majesty ES-2). They are intended for the following indications: - 1-Direct anterior and posterior restorations teeth (including occlusal surfaces) 2-Direct veneers 3-Correction of tooth position and tooth shape. 4-Indirect restorations including inlays,onlays and veneers 5-Intraoral repairs of fractured restorations 6-Core build-ups 7-Splinting ### Technological characteristics of device It can be said that subject devices (Medi Classic, Medi Pearl,Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl), are substantially equivalent in performance as well as those of the predicate device with the following characteristics: ### 1-Chemical ingredients All the chemical ingredients of the subject devices (Medi Classic, Medi Classic, Medi Pearl,Medi Jupiter Medi Opaque Plus, Medi Opaque Posterior, Medi White Peal) are used in the predicate devices, indicating the subject devices are substantially equivalent to the predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. {4}------------------------------------------------ ### 2-Performance Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl, Medi Opaque Plus, Medi Opaque Plus, Medi Opaque Posterior, Medi White Pearl) and the predicate device comply with ISO 4049:2009 indicating that the subject devices are substantially equivalent in performance to the predicate device (Clearfil Majesty ES-2). ### 3-Biocompatibility All the chemical ingredients of the subject devices(Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl), have been used in the predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subject devices are substantially equivalent in performance to the predicate device. # Section 5.3 Substantial Equivalence Discussion The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are similar to predicate device in terms of indication for use. design, chemical composition, physical properties and performance etc. The subject devices consist of multifunctional methacrylate resin base composite, as is the predicate device (Clearfi Majestx ES-2). The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of subject devices and Predicate Device Clearfil Majesty ES-2 fall within very similar values (Table.1). The physical properties and performance of subject devices are not significantly different from the predicate device (Clearfil Majesty ES-2), as indicated by non-clinical performance testing. The variety of shades and sizes are different between subject device and predicate device. | Table 1 Comparison of Subject Devices and Predicate Devices | | | | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Descriptive<br>Information | Subject Devices | Predicate Device | Summary | | Device Name | • Medi galaxy Flow<br>• Medi Classic<br>• Medi Pearl<br>• Medi Jupiter<br>• Medi Opaque Plus<br>• Medi Opaque Posterior<br>• Medi White Pearl | • Clearfil Majesty ES-2 | - | | Manufacturer | Swissmeditec GmbH | Kuraray Noritake Dental Inc. | - | | 510(k) | To be assigned | K121583 | - | | Application<br>Properties/<br>Delivery form | It is packaged in traditional syringes<br>or Pre-loaded tips (PLTs)<br>Accessory: Shade Guide | It is packaged in traditional syringes<br>or Pre-loaded tips (PLTs)<br>Accessory: Shade Guide | - | | Intended user | Dental professionals | Dental professionals | - | | Indications for | 1-Direct anterior and posterior restorations teeth (including occlusal surfaces)<br>2-Direct veneers<br>3-Correction of tooth position and tooth shape. | 1- Direct restorations for all cavity classes in anterior and posterior teeth<br>2- Direct veneers<br>3- Correction of tooth position and tooth shape (e.g. diastema closure, | Indications of the subject devices are the | | use | 4-Indirect restorations including<br>inlays, onlays and veneers<br>5-Intraoral repairs of fractured<br>restorations<br>6-Core build-ups<br>7-Splinting | dwarfed tooth, etc.)<br>4-Intraoral repairs of fractured<br>restorations | same as the<br>predicate device. | | Design | Screw top 2.5ml(4.5g) syringe and<br>Pre Loaded Tube 0.3 g | Screw top 2.0ml (3.6g) syringe and<br>Pre Loaded Tube 0.25 g | Subject devices<br>contain 25%<br>more composite<br>than predicate<br>device but have<br>the same design | | Composition of<br>Materials | Methacrylate-based resin, photo<br>initiator, fillers and pigments. | Methacrylate-based resin, photo Chemically<br>similar to the<br>predicate device. | | | Physical and<br>Performance<br>Properties | 1-Radiopacity: 2.10 (±0.04) mm Al<br>2-Compressive strength: 338-352<br>(±0.08) MPa<br>3-Elasticity modulus: 15.1(±0.07)<br>GPa<br>4-Fracture Toughness: 1.71 (±0.09)<br>MPa.m1/2<br>5-Surface Hardness (KHN): 75.03 ±<br>2.10<br>6-Flexural Strength: 131 (±14) MPa<br>7-Flexural Modulus: 10.6 (±0.6) MPa<br>8-Water Sorption: 23.1 (±2.1)<br>µg/mm3<br>9-Water Solubility: 1.0 (±0.7)<br>µg/mm3<br>10-Intensity for curing (for photo -<br>initiated resins):1200-2000 mW/cm2<br>11-wavelength for curing (for<br>photoinitiated resins):400-520 nm<br>12-Maximum absorbance 450-480<br>(468)nm<br>13-Depth of Cure: 2.22 (±0.03) mm<br>14-Curing time: 40 s/2mm | 1-Radiopacity: 2.13 (±0.08) mmAl<br>2-Compressive strength: 341(±0.11)<br>MPa<br>3-Elastic modulus: 14.8(±0.06) GPa<br>4-Fracture Toughness: 1.68 (±0.10)<br>MPa.m1/2<br>5-Surface Hardness (KHN): 71.07 ±<br>2.24<br>6-Flexural Strength: 127 (±10) MPa<br>7-Flexural Modulus: 11.6 (±0.8) MPa<br>8-Water Sorption: 19.3 (±1.9)<br>µg/mm3<br>9-Water Solubility: 0.8(±0.8)<br>µg/mm3<br>10-Intensity for curing (for photo -<br>initiated resins): 1200-2000 mW/cm2<br>11-wavelength for curing (for<br>photoinitiated resins) :400-520nm<br>12-Maximum absorbance 450-480<br>(468) nm<br>13-Depth of Cure: 2.40 (±0.02) mm<br>14-Curing time: 40 s/2mm | Physical and<br>performance<br>properties data<br>support<br>substantial<br>equivalence of<br>the Subject<br>devices when<br>compared to the<br>predicate device. | | FDA<br>Recognized<br>Standards | ISO 4049: 2009 | ISO 4049: 2009 | 4-181 | | Shelf Life | 36 month shelf life, room temperature | 36 month shelf life, room temperature | Same | ### Table 1 Comparison of Subject Devices and Predicate Devices {5}------------------------------------------------ ## SwissMediTec GmbH Traditional 510(K) ### CONCLUSIONS The indications and technological characteristics of subject devices (Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) are {6}------------------------------------------------ substantially equivalent to predicate device(Clearfil Majesty ES-2). Therefore, subject devices are substantially equivalent to the identified predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subiect devices are Substantially Equivalent in effectiveness to the predicate device # Section 5.4 Technological Characteristics It can be said that subject devices (Medi Classic, Medi Pearl,Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl), are substantially equivalent in performance as well as those of the predicate device with the following characteristics: ### 1-Chemical ingredients All the chemical ingredients of the subject devices (Medi Classic, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) are used in the predicate devices, indicating the subject devices are substantially equivalent to the predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. ### 2-Performance Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject devices(Medi galaxy Flow, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl) and the predicate device comply with ISO 4049:2009 indicating that the subject devices are substantially equivalent in performance to the predicate device. ### 3-Biocompatibility All the chemical ingredients of the subject devices(Medi galaxy Flow, Medi Classic, Medi Pearl,Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior,Medi White Pearl), have been used in the predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subject devices are substantially equivalent in performance to the predicate device. ## 4-Substantial Equivalence Discussion The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter, Medi Opaque Plus, Medi Opaque Posterior Medi White Pearl) are similar to predicate device in terms of indication for use, design, chemical composition, physical properties, performance, etc. The subject devices (Medi galaxy Flow. Medi Classic. Medi Pearl.Medi Jupiter.Medi Opaque Plus. Medi Opaque Posterior,Medi White Pearl) consist of multifunctional methacrylate resin base composite , as is the predicate device. The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of subject devices and Predicate Device Clearfil Majesty ES-2 fall within very similar values. The physical properties and performance of subject devices are not significantly different from the predicate device (Clearfil Majesty ES-2), as indicated by non-clinical performance testing. The variety of shades and sizes are different between subject device and predicate device. # Section 5.5 Performance Data Curing time evaluated according to ISO 10650-1 | Light Source | Curing time/sec. | Wavelength range and light intensity | Depth of cure/mm | |--------------|------------------|--------------------------------------|------------------| | | 20 | | 1.5 | {7}------------------------------------------------ # SwissMediTec GmbH Traditional 510(K) | 40 | 2.0 | |----------|----------| | ባበ<br>LU | <br>ﻝ، ﻠ | | 40 | 2.0 | | | Light source | Cure time/Sec. | Depth of cure/mm | |-------------------------|--------------|--------------------------------------------------------------------------------------|------------------| | | | A1, A2, A3, A3.5, A4, B1, B2, B3,<br>C2, C3, C4, D2, D3, D4, BL1, BL2,<br>E1, E2, E3 | OA2, OA3, OA4 | | Conventional<br>Halogen | | 20 | 1.5 | | | | | 1.0 | | LED | | 20 | 1.5 | | | | | 1.0 |