IMICRYL Composite, Composite Flow Materials

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 9, 2022 Imicryl Dis Malzemeleri Sanayi Ve Ticaret As Husamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No:5/201 Karatay Konya. 42030 Turkey Re: K220077 Trade/Device Name: IMICRYL Composite, Composite Flow Materials Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC, EJK Dated: July 5, 2022 Received: July 11, 2022 Dear Husamettin Sonmez: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220077 Device Name IMICRYL Composite, Composite Flow Materials Indications for Use (Describe) IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe) - · Direct anterior & posterior restorations - · Core Build Ups - · Splinting IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza) - · Class III, V & smaller Class IV restorations - · Base/liner in Class I & Class II restorations - · Repair resin, porcelain & acrylic temporary materials - · Pit & fissure sealant - · Undercut blockout - · Restoration of minimally invasive cavity preparations | 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. 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Composite Flow Materials The IMICRYL family of composite materials: includes the brand names Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. The IMICRYL family of composite flow materials: includes the brand names Nova Compo HF, Othocompo, Luxera, Maritza Date of Summary Preparation: November 30, 2021 Type of Submission: Traditional 510(k) #### SUBMITTER INFORMATION: Company Name: IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. Company Address: Fetih Mahallesi Mahir Sokak No: 5/201 Zip Code:42030 Karatay/Konya/TURKEY Phone Number: 0090 444 71 30 Fax Number: 0090 332 355 76 19 Contact Person: Husamettin SONMEZ Phone: 0090 444 71 30 ext: 120 E-mail: kaliteguvence@imicryl.com #### Secondary Contact Person: Muhammed Hulusi SONMEZ Phone: 0090 444 71 30 ext: 123 E-mail: hsonmez@imicryl.com.tr #### DEVICE INFORMATION: Trade Name: IMICRYL Composite, Composite Flow Materials Common Name: Composite Materials Primary Product Code: EBF Secondary Product Code: EJK, EBC Classification: Class II Classification Name: Tooth shade resin, material 21 CFR 872.3690 Regulation Number: 21 CFR 872.3690 Review Panel: Dental {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside, followed by the word "IMICRYL" in a bold, sans-serif font. Below the word is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in a smaller, sans-serif font. ## PREDICATE DEVICES: IMICRYL Composite, Composite Flow Materials is substantially equivalent to the following marketed product: | COMPANY | DEVICE | 510(k) NUMBER | PRODUCT CODE | |-------------|--------------------------------------------|---------------|--------------| | Silmet Ltd. | ProFil Composites (ProFil,<br>ProFil Flow) | K103190 | EBF | ## INDICATION FOR USE: IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe) - . Direct anterior & posterior restorations - Core Build Ups - Splinting IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza) - . Class III, V & smaller Class IV restorations - . Base/liner in Class I & Class II restorations - Repair resin, porcelain & acrylic temporary materials - . Pit & fissure sealant - . Undercut blockout - Restoration of minimally invasive cavity preparations ## DEVICE DESCRIPTION: IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light. IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity. There are differences in viscosity between composites and flowable composites. #### SUBSTANTIAL EQUIVALENCE: The applicant device has the same intended use as the 510(k) cleared predicates listed above. Table 1 below shows a comparison of IMICRYL Composite, Composite Flow Materials and the predicates. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol next to it. To the left of the word is a blue oval shape with the letters "IMI" inside. Below the word "IMICRYL" is the phrase "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters. ## Table 1: Comparison with Predicate Device | DESCRIPTIVE<br>INFORMATION | NEW DEVICE<br>IMICRYL Composite, Composite Flow Materials (K220077) | PREDICATE DEVICE<br>ProFil Composites (ProFil, ProFil Flow), [K103190] | REMARK | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | INDICATIONS FOR USE | | | | | | IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova<br>Compo HS, Balo, Swarpe) | ProFil | The indications for use of the new<br>device and the equivalent device<br>are the same. | | | Direct anterior & posterior restorations Core Build Ups Splinting | Direct anterior & posterior restorations Core Build Ups Splinting | | | | IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo,<br>Luxera, Maritza) | ProFil Flow | | | | Class III, V & smaller Class IV restorations Base/liner in Class I & Class II restorations Repair resin, porcelain & acrylic temporary materials Pit & fissure sealant Undercut blockout Restoration of minimally invasive cavity preparations | Class III, V & smaller Class IV restorations Base/liner in Class I & Class II restorations Repair resin, porcelain & acrylic temporary materials Pit & fissure sealant Undercut blockout Restoration of minimally invasive cavity preparations | | ## Similarities - · IMICRYL Composite, Composite Flow Materials it is exactly similar to the equivalent device in terms of composition ind physical properties. - We believe that the prior use of these components in leally marketed devices and the performance data and results support the safety and effectiveness of IMICRYL Composite Flow Materials for the intended use. ## Differences - There is no difference. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside, followed by the word "IMICRYL" in a bold, sans-serif font. Below the word is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in a smaller font. ## TECHNOLOGICAL PROPERTIES | Technological property | NEW DEVICE<br>IMICRYL Composite, Composite<br>Flow Materials (K220077) | PREDICATE DEVICE<br>ProFil Composites (ProFil,<br>ProFil Flow), [K103190] | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------| | Camphorquinone/amine<br>photoinitiator system | ✓ | ✓ | | Methacrylate-based resin matrix | ✓ | ✓ | | Silane treated fillers | ✓ | ✓ | | Bonded with a permanent dental<br>adhesive | ✓ | ✓ | | When irradiated by light, the<br>methacrylate functionalities of<br>the resins and surface treated<br>fillers undergo, in conjunction<br>with the photoinitiator system, I<br>light induced polymerization to<br>form a hard composite that is<br>bonded to the tooth structure<br>with a permanent dental<br>adhesive | ✓ | ✓ | ## NON-CLINICAL BENCH TESTING: IMICRYL COMPOSITE AND PROFIL COMPOSITE TEST RESULTS | Sample Name | Compressive<br>Strength<br>(MPa) | Flexural<br>Strength<br>(MPa) | Surface<br>Hardness<br>(MHV) | Water<br>Sorption<br>(µg/mm³) | Water<br>Solubility<br>(µg/mm³) | |-------------------------------------------------------|----------------------------------|-------------------------------|------------------------------|-------------------------------|---------------------------------| | IMICRYL<br>Composite,<br>Materials<br>(Lot No: 17125) | 420 MPa | 167 MPa | 265 MHV | 16.8 µg/mm³ | 0.3 µg/mm³ | | ProFil<br>Composite | 440 MPa | 187 MPa | 285 MHV | 18.4 µg/mm³ | 0.5 µg/mm³ | | Sample Name | Polymerization<br>Shrinkage | Diametral<br>Tensile<br>Strength | Flexural<br>Modulus | Radiopacity | Depth of<br>Cure | |--------------------------------------------|-----------------------------|----------------------------------|---------------------|---------------|------------------| | IMICRYL<br>Composite<br>(Lot No:<br>17125) | 1.45 % | 31 MPa | 126.87 MPa | 6 mm of Al | 2.5 mm | | ProFil<br>Composite | 1.57 % | 30 MPa | 130 MPa | 6.87 mm of Al | 2.8 mm | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside a stylized shape, followed by the word "IMICRYL" in bold, blue letters. Below the word "IMICRYL" is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." | Sample Name | Elastic<br>Modulus | Intensity for<br>Curing | Wavelength<br>for Curing | Filler Particle<br>Size<br>Distribution | |-----------------------------------------|--------------------|-----------------------------------------------------|--------------------------|-----------------------------------------| | IMICRYL<br>Composite<br>(Lot No: 17125) | 16.8 GPa | 1200 mW/cm2 –<br>10 sec.<br>500 mW/cm2 –<br>20 sec. | 470 nm | 0.7 μm | | ProFil<br>Composite | 17.1 GPa | 1200 mW/cm2 –<br>10 sec.<br>500 mW/cm2 –<br>20 sec. | 470 nm | 0.7 μm | | Sample Name | Working Time | Setting Time | Curing Time | |--------------------------------------|--------------|-----------------------|-------------| | IMICRYL Composite<br>(Lot No: 17125) | 38 second | 4 minute | 20 second | | ProFil Composite | 35 second | 4 minute 10<br>second | 20 second | ## IMICRYL COMPOSITE FLOW AND PROFIL COMPOSITE FLOW TEST RESULTS | Sample Name | Compressive<br>Strength<br>(MPa) | Flexural<br>Strength<br>(MPa) | Surface<br>Hardness<br>(MHV) | Water<br>Sorption<br>(µg/mm³) | Water<br>Solubility<br>(µg/mm³) | Sample Name | Polymerization<br>Shrinkage | Diametral<br>Tensile<br>Strength | Flexural<br>Modulus | Radiopacity | Depth of<br>Cure | |----------------------------------------------------|----------------------------------|-------------------------------|------------------------------|-------------------------------|---------------------------------|----------------------------------------------------|-----------------------------|----------------------------------|---------------------|--------------|------------------| | IMICRYL<br>Composite<br>Flow<br>(Lot No:<br>17126) | 380 MPa | 165 MPa | 265 MHV | 16.8 µg/mm³ | 0.3 µg/mm³ | IMICRYL<br>Composite<br>Flow<br>(Lot No:<br>17126) | 2.2 % | 68 MPa | 126.87 MPa | 3.5 mm of Al | 3.8 mm | | ProFil<br>Composite<br>Flow | 370 MPa | 160 MPa | 285 MHV | 18.4 µg/mm³ | 0.5 µg/mm³ | ProFil<br>Composite<br>Flow | 2 % | 65 MPa | 130 MPa | 3 mm of Al | 3 mm | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for IMICRYL. The logo consists of a blue circle with a white oval inside, containing the letters "IMI" in blue. To the right of the circle is the word "IMICRYL" in large, blue letters, with a registered trademark symbol above the "L". Below the circle and the word "IMICRYL" is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters. | Sample Name | Elastic<br>Modulus | Intensity for<br>Curing | Wavelength<br>for Curing | Filler Particle<br>Size<br>Distribution | Sample Name | Working Time | Setting Time | Curing Time | |----------------------------------------------|--------------------|---------------------------------------------------|--------------------------|-----------------------------------------|-------------------------------------------|--------------|-----------------------|-------------| | IMICRYL<br>Composite Flow<br>(Lot No: 17126) | 16.8 GPa | 1200 mW/cm² -<br>10 sec<br>500 mW/cm² –<br>20 sec | 470 nm | 0.7 μm | IMICRYL Composite<br>Flow (Lot No: 17126) | 38 second | 4 minute | 20 second | | ProFil<br>Composite Flow | 17.1 GPa | 1200 mW/cm² -<br>10 sec<br>500 mW/cm² –<br>20 sec | 470 nm | 0.7 μm | ProFil Composite Flow | 35 second | 4 minute 10<br>second | 20 second | ## NON-CLINICAL PERFORMANCE TESTING: #### Biocompatibility Testing: | Cytotoxicity | The device has not cytotoxic potential. | |-------------------------------------------|------------------------------------------------------------| | Sensitization | The device does not cause hypersensitive skin reaction. | | Intradermal Reactivity | The device does not cause intradermal irritation. | | Acute Systemic Toxicity | The device has no acute systemic toxic effect. | | Subacute Systemic Toxicity<br>(non-polar) | The device does not have a subacute systemic toxic effect. | | Subacute Systemic Toxicity<br>(polar) | The device does not have a subacute systemic toxic effect. | | Genotoxicity (OECD 471) | The device has no mutagenic potential. | | Genotoxicity (OECD 487) | The device has no genotoxic potential. | | Implantation | Irritant effect was not found. | #### Physical Testing: In-vitro bench tests were performed on the IMICRYL Composite Flow Materials according to the requirements in ISO 4049 Dentistry -- Polymer-based restorative materials and ISO 17304 Dentistry — Polymerization Shrinkage: Method For Determination of Polymerization Shrinkage of Polymer-Based Restorative Materials. Bench tests included in support of the substantial equivalence of IMICRYL Composite, Composite Flow are: - Compressive Strength . - . Flexural Strength - Surface Hardness ● - . Water Sorption and Solubility - . Polymerization Shrinkage - Diametral Tensile Strength - Flexural Modulus ● - . Radiopacity - . Depth of Cure {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for IMICRYL. The logo consists of the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol next to it. To the left of the word is a blue circle containing the letters "IMI" in white. Below the word "IMICRYL" is the phrase "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters. ## CONCLUSION In accordance with 21 C.F.R part 807 and FDA' s "Guidance for the preparation of Premarket Notifications for Dental Composites" and based on the information provided in this premarket notification, IMICRYL AS. concludes that IMICRYL Composite, Composite Flow Materials are safe and effective and substantially equivalent to the predicate devices described herein.