Surefil one Self-adhesive Composite Hybrid

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January 23, 2020 Dentsply Sirona Karl Nittinger Vice President Corporate Regulatory Affairs 221 W Philadelphia Street, Suite 60W York, Pennsylvania 17401 Re: K192530 Trade/Device Name: Surefil one™ Self-adhesive Composite Hybrid Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 24, 2019 Received: December 26, 2019 Dear Karl Nittinger: 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). 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Sincerely, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192530 Device Name Surefil one™ Self-adhesive Composite Hybrid Indications for Use (Describe) Class I to Class V restorations Core build up Type of Use (Select one or both, as applicable) > 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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Traditional 510(k)- Surefil one Self-adhesive Composite Hybrid {3}------------------------------------------------ Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is a dark gray color. # 510(k) SUMMARY For: K192530 Surefil one™ Self-adhesive Composite Hybrid ### 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 Contact Person: Karl Nittinger Email: karl.nittinger@dentsplysirona.com Telephone Number: 717-849-4424 Fax Number: 717-849-4343 Date Prepared: 20 December 2019 Dental cement Surefil one™ Self-adhesive Composite Hybrid ### 2. Device Name: - Proprietary Name: . - Classification Name: ● - CFR Number: ● - Device Class: ● - Product Code: . - EMA 872.3275 - Predicate Device: 3. | Predicate Device | 510(k) | Company Name | |------------------------------------------|---------|----------------------| | Primary Predicate:<br>Pulpdent RMGI FILL | K130223 | Pulpdent Corporation | | Reference Device | 510k) | Company Name | | Secondary Predicate:<br>GC Fuji Direct | K172382 | GC America Inc. | - 4. Description of Device: The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule. The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features: - · Self-adhesiveness to enamel and dentin - · Fluoride release - · Bulk fill and dual-cure - · Radiopacity (equivalent to 2mm aluminum). {4}------------------------------------------------ ### 5. Indications for Use: - Class I to Class V restorations - . Core build up - Substantial Equivalence: 6. ## Technological Characteristics | Proposed Device<br>Surefil one™<br>Self-adhesive<br>Composite Hybrid<br>K192530 | Primary Predicate<br>Device<br>Pulpdent RMGI FILL<br>K130223 | Reference Device<br>GC Fuji Direct<br>K172382 | Differences | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use:<br>• Class I to Class<br>V restorations<br>• Core build up | Indications for Use:<br>Resin-modified glass<br>ionomer preparation<br>used by dental<br>professionals as filling<br>material in dental<br>restorations | Indications for Use:<br>1. Class III and V restorations<br>2. Restoration of primary teeth<br>3. Core build-up<br>4. Cases where radiopacity is<br>required<br>5. Base material for Class I and<br>Class II cavities using a<br>sandwich laminate technique | The verbiage describing the indications<br>for Use of Surefil one™ Self-adhesive<br>Composite Hybrid and the primary<br>predicate, Pulpdent RMGI FILL is<br>different. The wording used by the<br>primary predicate (namely: "as filling<br>material in dental restorations")<br>describes a much broader field.<br>The reference device indications when<br>compared to the proposed Surefil<br>one™ Self-adhesive Composite Hybrid<br>lists the cavity classes and the core<br>build-up, respectively. | | Features: | Features: | | | | Self-adhesive composite<br>hybrid restorative | Resin-modified glass<br>ionomer<br>(self-adhesive since no<br>use of dental adhesive is<br>required according to the<br>Instructions for Use) | Resin-modified glass ionomer<br>(No need for etchant and adhesive) | Composite hybrid restorative is based<br>on resin-modified glass ionomer<br>chemistry. By its chemistry, resin<br>modified glass-ionomers exhibit self-<br>adhesive properties to enamel and<br>dentin. | | Proposed Device<br>Surefil one™<br>Self-adhesive<br>Composite Hybrid<br>K192530 | Primary Predicate<br>Device<br>Pulpdent RMGI FILL<br>K130223 | Reference Device<br>GC Fuji Direct<br>K172382 | Differences | | Powder/liquid<br>formulation in a mixing<br>capsule | Paste/paste formulation<br>in a double-chamber<br>syringe | Paste/paste formulation in a double-<br>chamber syringe. | The final delivery form of the proposed<br>device into the teeth is a paste and therefore<br>the same as the predicate devices. | | Triple cure<br>- Light-curing<br>- Self-curing<br>- Acid-base<br>reaction | Triple cure<br>- Light-curing<br>- Self-curing<br>- Acid-<br>base | Acid-base reaction and polymerization of<br>methacrylate monomers through dual cure | No difference between the proposed device<br>and the primary predicate device. The<br>reference only has dual cure feature. | | Fluoride release | Release calcium,<br>phosphate and fluoride | Bioactive material with high fluoride<br>release | Release of calcium, release of phosphate<br>ions and bioactive material are not a<br>proposed feature for the subject device,<br>Surefil one™ Self- adhesive Composite<br>Hybrid device. | | Sterility:<br>Non-sterile when used. | Sterility:<br>Non-sterile when used | Sterility:<br>Non-sterile when used | Sterility of the proposed device is identical<br>to the predicate and reference devices. | | Storage Temp:<br>2°C - 24°C | Storage Temp:<br>"Cool room temperature" * | Storage Temp:<br>4°C - 25°C | Storage temperature differs for the proposed<br>device compared to the predicate and<br>referenced devices. Test data is included to<br>support that proposed device meets its identified<br>requirements when stored within the identified<br>temperature range. | | Shelf Life:<br>10 months | Shelf Life:<br>2 years* | Shelf Life:<br>2 years | The initial shelf life of the proposed device is<br>more limited than that of the predicate and<br>reference devices. Shelf life data is included to<br>verify that the proposed device meets its<br>identified requirements throughout the proposed<br>shelf life. | | Available Shades:<br>A1, A2, A3, A3.5, Bleach White | Available Shades*:<br>A1, A2, A3, A3.5 | Available Shades:<br>A1, A2, A3 | The proposed device is offered in identical<br>shades as the predicate with the addition of<br>bleach white. | | Application System:<br>Pre-dosed capsule and<br>extruder. | Application System:<br>Dual chamber syringe | Application System:<br>Direct dispensed or manual application after<br>mixing. | Proposed, predicate and reference devices can<br>be direct dispensed. | | * Obtained from publicly available labeling. | | | | {5}------------------------------------------------ {6}------------------------------------------------ ### 7. Non-Clinical Performance Data: In-vitro bench tests were performed on the Surefil one™ Self-adhesive Composite Hybrid according to the requirements in ISO 9917-2:2017 (Dentistry -Water based cements - part 2: Resin-modified cements) and internal Dentsply Sirona criteria. Bench tests included in support of substantial equivalence of Surefil one™ Selfadhesive Composite Hybrid. Compartative tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223). A summary list of testing conducted in support of substantial equivalence is as follows: - Compressive strength ● - Flexural strength ● - Setting time - Radio-opacity ● - Shear bond strength to enamel ● - Shear bond strength to dentin - Shear bond strength to composite ● - Enamel wear ● - . ACTA (Academic Center for Dentistry Amsterdam) wear test The performance of the Surefil one™ Self-adhesive Composite Hybrid satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence. Cytotoxicity testing was performed for Surefil one™ Self-adhesive Composite Hybrid as well as chemical analysis of leachable organic and inorganic compounds in compliance with the standard EN ISO 10993-1. The results of the biocompatibility testing and chemical analysis conducted relating to the subject Surefil one™ Self-adhesive Composite Hybrid support its substantial equivalence. #### 8. Clinical Performance Data No data from human clinical studies has been included to support the substantial equivalence of the Surefil one™ Self-adhesive Composite Hybrid. #### 9. Conclusion Regarding Substantial Equivalence The Surefil one™ Self-adhesive Composite Hybrid has the same intended use and has similar indications for use as the primary predicate Pulpdent RMGI FILL (K130223) and the secondary predicate GC Fuji Direct (K172382). Test data to verify the performance of the Surefil one™ Self-adhesive Composite Hybrid has been provided including: compressive and flexural strength, adhesion to enamel, dentin and composite, setting time, ACTA (Academic Center for Dentistry Amsterdam) wear, enamel wear and radio-opacity and the results of this testing, combined with the design and intended use comparison with the primary predicate device, support substantial equivalence.