TPH Spectra ST Flowable Composite Restorative

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November 20, 2018 Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401 Re: K182288 Trade/Device Name: TPH Spectra ST Flowable Composite Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 21, 2018 Received: August 23, 2018 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. 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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Mary Mary S. S. Runner -S3 Date: 2018.11.20 Runner -S3 12:24:31 -05'00' 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) K182288 #### Device Name TPH Spectra® ST Flowable Composite Restorative Indications for Use (Describe) TPH Spectra® ST Flowable Composite Restorative is indicated for: - Direct restoration of cavities and lesions - · Filling of defects and undercuts in crowns, inlays, and onlays - Blockouts - · Repair of defects - · Pit and fissure sealants - · Cementation of light transmissible indirect restorations 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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To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font and in the same gray color as the abstract shape. #### K182288 510(k) SUMMARY TPH Spectra® ST Flowable Composite Restorative Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite eow York, PA 17401 Contact Person: Karl Nittinger Telephone Number: 717-849-4424 717-849-4343 Fax Number: Date Prepared: August 21, 2018 Device Name: - Proprietary Name: TPH Spectra® ST Flowable Composite . - Restorative - Classification Name: Tooth Shade Resin Material . - CFR Number: ● - 872.3690 - . Device Class: Product Code: EBF . - ## Predicate Device: | Company | Device | Predicate /<br>Reference | 510(k) | Product<br>Code | |-----------------------------|------------------------|--------------------------|---------|-----------------| | Shofu Dental<br>Corporation | Beautifil Flow<br>Plus | Predicate | K101603 | EBF | | Dentsply<br>International | Flowable<br>Composite | Reference | K981965 | EMA | ## Description of Device: TPH Spectra® ST Flowable Composite Restorative is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior teeth. The new device contains methacrylate-based resin, photo initiator, silanated inorganic filler and pigments. Available shades include opaque dentin shades, regular body shades and translucent enamel shades. {4}------------------------------------------------ TPH Spectra® ST Flowable Composite Restorative is applied to the tooth following use of a methacrylate-based dental adhesive and/or a cement, which bonds the restoration to the tooth structure. TPH Spectra® ST Flowable Composite Restorative is packaged in multi-use dispensing packages and pre-dosed Compula® Tips for intraoral dispensing. #### Indications for Use: TPH Spectra® ST Flowable Composite Restorative is indicated for: - Direct restoration of cavities and lesions ● - Filling of defects and undercuts in crowns, inlays, and onlays ● - Blockouts - Repair of defects ● - Pit and fissure sealants ● - Cementation of light transmissible indirect restorations ● ## Substantial Equivalence: ## Technological Characteristics: Information provided in this 510(k) submission supports the substantial equivalence of TPH Spectra® ST Flowable Composite Restorative when compared to the predicate device, Beautifil Flow Plus (K101603), and the reference device, Flowable Composite (K981965), in terms of intended use, indications for use, composition, physical properties and technological characteristics. The subject device has similar indications for use as those cleared for the predicate device (K101603). Both are indicated for direct restoration of cavities and lesions, as well as, repairs. The reference device (K981965), which, like the subject device, is also a methacrylate-based flowable composite material, is included in support of substantial equivalence as it is cleared for the; filling of defects and undercuts in crowns, inlays, and onlays; blockouts; and pit and fissures sealant indications as are included in the indications for use of the subject TPH Spectra® ST Flowable Composite Restorative. As a tooth shade resin material classified under 21 CFR 872.3690, the subject TPH Spectra® ST Flowable Composite Restorative has the same intended use as the predicate Beautiful Flow Plus (K101603). The subject TPH Spectra® ST Flowable Composite Restorative incorporates the same fundamental technology (low-viscosity, methacrylate-based composite resin) and its physical properties conform to the same recognized consensus standard as do the properties of the predicate device (K101603). Tables 5.1 and 5.2 are presented in teh following pages to summarize the indicaitions for use and technical comparison of the subect TPH Spectra® ST Flowable Composite Restorative to the precdicate and reference devices. {5}------------------------------------------------ Table 5.1-Comparison of the proposed TPH Spectra® ST Flowable Composite Restorative and the Predicate Device, Beautifil Flow Plus (K101603) | Proposed Device<br>TPH Spectra® ST Flowable<br>Composite Restorative | Predicate Device<br>Beautifil Flow Plus<br>(K101603) | Differences | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use:<br>• Direct restoration of cavities and<br>lesions<br>• Filling of defects and undercuts<br>in crowns, inlays, and onlays<br>• Blockouts<br>• Repair of defects<br>• Pit and fissure sealants<br>• Cementation of light<br>transmissible indirect restorations | Indications for Use:<br>• Beautifil Flow Plus is a light-<br>curing dental filling material<br>having low viscosity<br>intended to directly restore<br>cavities and lesions (except<br>for root canal filling), and to<br>repair fractured artificial<br>crowns. | The Indications for Use of the proposed device are similar to the<br>predicate device.<br>"Filling of defects and undercuts in crowns, inlays, and onlays" and<br>"Blockouts" are not specific indications for use of the primary<br>predicate device. However, the reference device is included in<br>support of substantial equivlance, incorporates the same technology<br>as the subject device, and includes these indications.<br>"Repair of defects" is a general description of all direct or indirect<br>repairs, e.g. repair of fractured artificial crowns in the predicate device.<br>"Pit and fissure sealants" and "Cementation of light transmissible<br>indirect restorations" are not the indications of this predicate device. | | Composition of Materials:<br>Methacrylate-based resins, photo<br>initiators, fillers and pigments. | Composition of Materials:<br>Methacrylate-based resins,<br>photo initiators, fillers and<br>pigments. | Chemically similar to the predicate device. | | Physical Properties:<br>Meet ISO 4049:2009 requirements. | Physical Properties:<br>Meet ISO 4049:2009<br>requirements. | Physical Property data similar to the predicate device. | {6}------------------------------------------------ Table 5.2-Comparison of the proposed TPH Spectra® ST Flowable Composite Restorative and the reference device, Flowable Composite (K981965) | Proposed Device<br>(K981965) | Reference Device<br>(K981965) | Differences | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | TPH Spectra® ST Flowable<br>Composite Restorative | Flowable Composite | | | <b>Indications for Use:</b><br>• Direct restoration of cavities<br>and lesions<br>• Filling of defects and<br>undercuts in crowns, inlays,<br>and onlays<br>• Blockouts<br>• Repair of defects<br>• Pit and fissure sealants<br>• Cementation of light<br>transmissible indirect<br>restorations | <b>Indications for Use:</b><br>• Filling of defects and undercuts in<br>crowns, inlays and onlays<br>• Liner under direct restorative<br>materials and under inlay<br>restorations – Class II box liner<br>• Tunnel preparations<br>• Pit and fissure sealants<br>• Amalgam margin repair<br>• Improving margins of acrylic<br>temporaries<br>• Small Class IV repairs<br>• Intraoral porcelain repair<br>• Cementing porcelain veneers,<br>crowns, inlays/onlays<br>• Refacing acrylic temporaries<br>• Blockouts<br>• Covering incisal edge stains<br>• Repair of small enamel defects<br>• Provisional occlusal changes<br>• Class III, V restorations<br>• Conservative Class I restorations<br>• Margin correction / adjustment of<br>composite crowns for indirect<br>laboratory use | The Indications for Use of the proposed device is similar to the<br>reference device.<br><br>"Direct restoration of cavities and lesions" is a general description<br>of all direct restoration indications of the reference device. Class I,<br>Class II and Class IV restorations are not the indications of this<br>reference device.<br><br>"Repair of defects" is a general description of all direct or indirect<br>repair indications of the reference device. | | <b>Composition of Materials:</b> | <b>Composition of Materials:</b> | Chemically similar to the reference device. | | Methacrylate-based resins, photo<br>initiators, fillers and pigments. | Methacrylate-based resins, photo<br>initiators, fillers and pigments. | | | <b>Physical Properties:</b> | <b>Physical Properties:</b> | Physical Property data similar to the reference device. | | Meet ISO 4049:2009<br>requirements. | Meet ISO 4049:2009 requirements. | | {7}------------------------------------------------ ## Biocompatibility Testing: An evaluation of biocompatibility was performed for the TPH Spectra® ST Flowable Composite Restorative in accordance with ISO 10993-1(Biological Evaluation of Medical Devices- Part1: Evaluation and Testing), ISO 7405 (Dentistry - Evaluation of Biocompatibility of Medical Devices used in Dentistry) and FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". In support of substantial equivalence, biocompatibility test data on the TPH Spectra® ST Flowable Composite Restorative have been included. The biocompatibility data support a conclusion that the TPH Spectra® ST Flowable Composite Restorative met the requirements of the following biological evaluations: - Cytotoxicity Using the Colony Assay - ISO Intracutaneous Study ● - ISO Maximization Sensitization Test - Genotoxicity: Bacterial Reverse Mutation Study ● - Genotoxicity: Mouse Lymphoma Assay ● ## Physical Properties: In-vitro bench tests were performed on the TPH Spectra® ST Flowable Composite Restorative according to the requirements in ISO 4049: 2009 (Dentistry - Polymer-based restorative) and internal Dentsply Sirona internal criteria. Bench tests included in support of the substantial equivalence of TPH Spectra® Flowable Composite Restorative are: - . Compressive Strength - Flexural Strength ● - Surface Hardness ● - Radiopacity - Water Sorption ● - Water Solubility ● - Sensitivity to Ambient Light ● - Fracture Toughness ● - Localized Wear Volume Loss ● - Fluoride Ion Release Characterization ● - Shade and Color Stability ● - Film Thickness . The results from bench tests included in this premarket notification support the substantial equivalence of the TPH Spectra® ST Flowable Composite Restorative. {8}------------------------------------------------ #### Clinical Performance Data: No data from human clinical studies has been included to support the substantial equivalence of the proposed device TPH Spectra® ST Flowable Composite Restorative. #### Conclusion Regarding Substantial Equivalence: The similarities in technology and indications for use, together with results of non-clinical performance testing and biocompatibility testing, support that TPH Spectra® ST Flowable Composite is substantially equivalent to the predicate devices.