Who is the manufacturer of Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

Prevest Denpro Limited filed the 510(k) submission for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (K231263).

What is the FDA product code for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

Q: What are the predicate devices for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT?

Opallis (K201707); Build-it Total Core (K102703); Tetric Evoflow (K993783); Constic (K102603).

K231263 · Prevest Denpro Limited · EBF · Jan 5, 2024 · Dental

Device Facts

Record ID	K231263
Device Name	Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
Applicant	Prevest Denpro Limited
Product Code	EBF · Dental
Decision Date	Jan 5, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material. Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts. Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosions, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations, Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant. Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.

Device Story

Resin-based dental composites; supplied in syringes/auto-mix systems. Used by dentists for restorative procedures. Fusion Core DC Flo: dual-cure (light/chemical) for core build-up. Fusion Flo/Magma NT: light-cured restorative materials. Fusion Flo SE: self-etch/self-adhesive flowable composite. Fusion I-Seal: light-cured liner/sealant. Principle: photosensitive initiator system (camphorquinone) activated by dental curing light (400-500nm) to polymerize resin matrix; dual-cure versions utilize chemical initiators for areas inaccessible to light. Output: hardened dental material restoring tooth structure/function. Benefits: improved aesthetics, structural integrity, and simplified clinical application.

Clinical Evidence

Bench testing only. Evaluated per ISO 4049:2019 and ISO 13116:2014. Metrics: flexural strength, film thickness, water sorption, water solubility, working/setting time, depth of cure, radio-opacity, and pH (Fusion Flo SE). All results met ISO criteria.

Technological Characteristics

Resin-based composites; matrix includes Bis-GMA, TEGDMA, UDMA. Fillers: silanated barium borosilicate glass, fumed silica, ytterbium fluoride. Curing: light-activated (400-450nm) or dual-cure (chemical/light). Delivery: syringe/auto-mix. Radiopaque. Complies with ISO 4049, ISO 13116, ISO 9917-2.

Indications for Use

Indicated for dental patients requiring direct restorations (Classes I-V), core build-ups, cavity lining, pit/fissure sealing, or composite/ceramic repairs. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

Opallis (K201707)
Build-it Total Core (K102703)
Tetric Evoflow (K993783)
Constic (K102603)

Reference Devices

everX Posterior (K153127)
Cal LC (K212457)
Tetric Evoceram (K042819)
Opallis Flow (K201707)
Evadyne (K111666)

Related Devices

K213339 — DENU Composite Resin, DENU Flow Resin · Hdi, Inc. · Sep 23, 2022
K121880 — DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID · Danville Materials, Inc. · Sep 25, 2012
K151399 — Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow · Schutz Dental GmbH · Oct 24, 2016
K161353 — ESTELITE BULK FILL Flow · Tokuyama Dental Corporation · Apr 3, 2017
K201707 — Opallis, Opallis Flow · Dentscare Ltda · Dec 22, 2020

Submission Summary (Full Text)

{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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 5, 2024 Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172 Re: K231263 Trade/Device Name: Prevest Denpro Composite Resins: Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: December 7, 2023 Received: December 8, 2023 Dear Angela Blackwell: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231263 Device Name Prevest Denpro Composite Resins Fusion Core DC Flo, Fusion Flo SE, Fusion I Seal, and Magma NT Indications for Use (Describe) Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material. Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts. Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosions, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations, Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant. Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs. 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. 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." {4}------------------------------------------------ # Prevest DenPro Composites (Fusion Core DC Flo, Fusion Flo, Fusion Flo SE, Fusion I Seal, Magma NT) 510(k) Summary - K231263 January 4, 2024 Name and Address: Prevest Denpro Limited Unit II, Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280 Name of device: Prevest Denpro Composites (Fusion Core DC Flo, Fusion Flo, Fusion Flo SE, Fusion I Seal, Magma NT) Classification Name: tooth shade resin material CFR: 21 CFR 872.3690 Primary Product Code: EBF Regulatory Class: II #### Submission Contact: Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com #### Device Description: Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system. Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites. Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites. Fusion I-Seal is a single component, light cured flowable composite. Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth. #### Indications for Use: {5}------------------------------------------------ | Device Name | Indications | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fusion Core DC Flo | Fusion Core DC Flo is indicated for use as 1. Core build up material on vital and non-vital teeth 2. Sealing root canal openings, 3. Cavity floor liner, 4. Post cementation, 5. Restorative material 6. Dentin replacement material. | | Fusion Flo | Fusion Flo is indicated for direct filling of • class V restorations (cervical caries, root erosions, wedge shaped defects). • Anterior restorations (Class III & IV). • Small posterior restorations • Repair of composite/ceramic veneers • Blocking out of undercuts | | Fusion Flo SE | Fusion Flo SE is indicated for direct filling of • class V (cervical caries, root erosion, wedge shaped defects). • Anterior restorations (Class III & IV) • Small posterior restorations | | Fusion I Seal | Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant. | | Magma NT | Magma NT is indicated for -direct restoration in anterior and posterior teeth Classes I, II, III, IV and V -porcelain/composite repairs | ## Testing Summary: Fusion Core DC Flo was tested for appearance, flexural strength, film thickness, water sorption, water solubility, working time, and setting time according to protocols based on ISO 4049: 2019 and tested for radio-opacity according to a protocol based on ISO 4049:2019 & ISO 13116:2014. Fusion Flo, Fusion Flo SE and Magma NT were tested for appearance, flexural strength, sensitivity to ambient light, depth of cure, water sorption, water solubility, and color & shade stability according to protocols based on ISO 4049: 2019 and tested for radio-opacity according to a protocol based on ISO 4049:2019 & ISO 13116:2014. Fusion Flo SE was also tested for pH according to a protocol based on USP 971. Fusion I Seal was tested for appearance, flexural strength, depth of cure, water sorption and water solubility according to protocols based on ISO 4049:2019, and radio-opacity according to a protocol based on ISO 4049:2019 and ISO 13116: 2014. All test results met the criteria in standards. {6}------------------------------------------------ Shelf life for the composites other than Fusion Core DC Flo is 3 years. Fusion Core DC Flo has a shelf life of 2 years. All shelf life determinations use the same testing protocols as the characterization testing which are based on ISO 4049:2019. The predicate and reference devices use the same ISO standard for their testing. Their shelf lives are 3 years or are not given. Predicate Device: Opallis K201707, Build-it Total Core K102703, Tetric Evoflow K993783, Constic K102603 Reference Devices: everX Posterior K153127, Cal LC K212457, Tetric Evoceram K042819, Opallis Flow K201707, Evadyne K111666 #### Substantial Equivalence: The composites have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing. ### Composite Materials from Prevest Denpro | | Fusion Core DC Flo | Build-It Total Core K102703 From Sybron Predicate Device | everX Posterior K153127 from GC America Reference Device | Cal LC K212457 from Prevest Denpro Reference Device | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | EBF | EBF | EJK | EJK | | Indications for Use | Fusion Core DC Flo is indicated for use as 1. Core build up material on vital and non-vital teeth 2. Sealing root canal openings, 3. Cavity floor liner, 4. Post cementation, 5. Restorative material 6. Dentin replacement material. | Build-it Total Core is indicated for use as 1. Core build up material on vital and non-vital teeth 2. Sealing root canal openings, 3. Cavity floor liner, 4. Post cementation, 5. Restorative material 6. Dentin replacement material. | everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin. | Cal LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled. | | Mechanism of Action | Dual cure core build-up materials consist of a resin matrix, fillers, and a combination of light curing photopolymerizing agents and chemical curing agents. This | Dual cure core build-up materials consist of a resin matrix, fillers, and a combination of light curing photopolymerizing agents and | | | | | offers the assurance of complete curing even in areas that may be hard to reach for the curing light. Curing times vary but are often completed within 5 minutes. The dual cured composite at the top surface is mainly polymerized through photo- initiated chemical reactions, while at the bottom surface it is done via chemically initiated polymerization. | chemical curing agents. This offers the assurance of complete curing even in areas that may be hard to reach for the curing light. Curing times vary but are often completed within 5 minutes. The dual cured composite at the top surface is mainly polymerized through photo- initiated chemical reactions, while at the bottom surface it is done via chemically initiated polymerization. | | | | Applicable Standards | ISO 4049, 13116:2014 | ISO 4049 | ISO 4049, ISO 9917-2 | ISO 4049, ISO 9917-2 | | Composition | Base: Bisphenol A Glycidyl Methacrylate Ethoxylated Bisphenol A Dimethacrylate Triethylene Glycol Dimethacrylate Silanated Barium Borosilicate Glass Powder Silanated Fumed Silica | Triethylene glycol dimethyl acrylate Urethane dimethyl acrylate Fluoride Barium borosilicate glass fillers 4-META | Bisphenol A Glycidyl Methacrylate polymethylmethacrylate Triethylene glycolDimethacrylate. Salinated E-glass fiber Barium Glass | Urethane Dimethacrylate Triethylene Glycol Dimethacrylate Silanated Barium Borosilicate Glass Powder Silanated Amorphous Silica Calcium Hydroxide | {7}------------------------------------------------ {8}------------------------------------------------ | Butylated hydroxy toluene (BHT) Fumed Silica Benzoyl peroxide Yetterbium Fluoride Catalyst: Bisphenol A Glycidyl Methacrylat e Ethoxylated Bisphenol A Dimethacryl ate Triethylene Glycol Dimethacryl ate Silanated Barium Glass Powder Silanated Fumed Silica Camphorquinone Butylated hydroxy toluene (BHT) Fumed Silica Yetterbium Fluoride Ethyl -4- dimethyl amino benzoate 2-dimethyl amino ethyl Methyacryla te | | sulphate DL Camphorquinone 2-Dimethyl Amino Ethyl Methacrylate Ethyl4Dimethyl Amino Benzoate Butylated Hydroxy Toluene. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------| {9}------------------------------------------------ | | • Dihydroxy ethyl p-toluidiene • Titanium Dioxide | | | | |------------------------------------------------------------|------------------------------------------------------|---------------------------------------|------------------------|---------------------------------| | Flexural Strength | ≥50 MPa | Complies with ISO 4049 | Complies with ISO 4049 | 96.3 MPa | | Light Intensity (mW/cm²) And Curing Time (sec) | ≤600 40 750 20 1200 10 | ≥600 20 | >1200 10 700 20 | | | Wavelength for Curing (nm) | 400-450 | 400-450 | 400-450 | | | Depth of Cure (mm) | Not applicable | 10mm | 4mm | | | Working Time (min:sec) Dual Cure | 1:25 | | | | | Setting Time (min:sec) Dual Cure | 3:20 | | | | | Filler particle size (μ) | 2 | | | 0.3-10 | | Filler loading (% Volume) | 65 | | | 45.8 | | Radio Opacity | 3mm compared with aluminium wedge | Complies with ISO 4049, 13116:2014 | Complies with ISO 4049 | Complies with ISO 13116:2014 | | Water Sorption | maximum of 40 µg/mm3 | Complies with ISO 4049 | Complies with ISO 4049 | Complies with ISO 4049 | | Water Solubility | maximum of 7.5 um/mm³ | 1 g/L | Complies with ISO 4049 | Complies with ISO 4049 | | | Fusion Flo | Opallis Flow K201707 from FGM Dental Group Reference Device | Tetric Evoflow K993783 from Ivoclar Predicate Device | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | EBF | EBF | EBF | | Indications for Use | Fusion Flo is indicated for direct filling of | Base/lining underneath direct restorations. - Small, non-occlusal stress- bearing class I restorations | • Class V restorations (cervical caries, | | | class V restorations (cervical caries, root erosions, wedge shaped defects). Anterior restorations (Class III & IV). Small posterior restorations Repair of composite/ceramic veneers Blocking out of undercuts | according to minimally invasive filling therapy Pit and fissure sealant. Tunnel-type preparation. Repair of enamel defects. Bonding of tooth fragments. Repairs in composite resin. Non-carious cervical lesions Planning of preparation walls | root erosion, wedge shaped defects) Anterior restorations (Class III and IV) Small posterior restorations Restorative therapy for mini-cavities of all types (preparation with Sonic-Sys Micro Instruments from Kavo) Adhesive cementation of Sonic-Sys inlays Extended fissure sealings in molars and pre-molars Repair of composite/ceramic veneers Blocking out of undercuts Adhesive cementation of ceramic and composite restorations | | Mechanism of Action | Flowable resin-based composites are conventional composites with the filler loading reduced by volume as compared to conventional composites. This altered filler loading modifies the viscosity of these materials. The flowable composites are packed in small syringes that allow for easy dispensing with very small gauge needles. This makes them ideal for use in small | Flowable resin-based composites are conventional composites with the filler loading reduced by volume as compared to conventional composites. This altered filler loading modifies the viscosity of these materials. The flowable composites are packed in small syringes that allow for easy dispensing with very small gauge needles. This makes them ideal for use in small | Flowable resin-based composites are conventional composites with the filler loading reduced by volume as compared to conventional composites. This altered filler loading modifies the viscosity of these materials. The flowable composites are packed in small syringes that allow for | | | preparations that would be difficult to fill otherwise. The photosensitive initiator system and a light source are used to activate the light-cure resin, which is delivered as a single paste and can only cure to a depth of 2 to 3mm. | preparations that would be difficult to fill otherwise. The photosensitive initiator system and a light source are used to activate the light-cure resin, which is delivered as a single paste and can only cure to a depth of 2 to 3mm. | easy dispensing with very small gauge needles. This makes them ideal for use in small preparations that would be difficult to fill otherwise. The photosensitive initiator system and a light source are used to activate the light- cure resin, which is delivered as a single paste and can only cure to a depth of 2 to 3mm. | | Composition | ● Bisphenol A Glycidyl Methacrylate ● Ethoxylated Bisphenol A Dimethacrylate ● Urethane Dimethacrylate ● Triethylene Glycol Dimethacrylate ● Barium Glass Powder ● Fumed Silica ● Silanated ● Amorphous Silica ● camphorquinone ● Ethyl 4-( dimethyl amino benzoate) ● 2- Dimethylethylmetha acrylate ● Butylated Hydroxy Toluene ● Titanium Dioxide ● Iron oxide | ● Bisphenol A Glycidyl Methacrylate ● Ethoxylated Bisphenol A Dimethacrylate ● Urethane Dimethacrylate ● Triethylene Glycol Dimethacrylate ● Fillers: Barium- Aluminum, silanized ● Silicate ● silicon dioxide ● camphoroquinone ● accelerators ● stabilizers and pigments. | ● Ba-Al-silicate glass ● Copolymer ● Mixed oxide ● Ytterbium Trifluoride ● Silicone dioxide | | Applicable Standards | ISO 4049, 13116:2014 | ISO 4049 | ISO 4049 | | Flexural Strength | ≥ 80 MPa | 137.80 MPa | 114 MPa | | Light Intensity (mW/cm²) And Curing Time (sec) | ≤600 40 750 20 1200 10 | ≥500 40 | ≥500 10 | | Wavelength for Curing (nm) | 400-450 | 400-500 | 400-500 | | Depth of Cure | 1.00 mm (opaque) / 1.5 mm (others) minimum | ≤2mm | ≥1.5mm dentin and bleach XL ≥2mm other shades | | Filler particle size (μ) | 1 | 0.05-5 | 1 | | Filler loading (% Volume) | 62 | 72 | 61 | | Water Sorption | ≤40 µg/mm3 | 27.92 µg/mm³ | 21.0 µg/mm³ | | Water Solubility | maximum of 7.5 µm/mm³ | 5.46 µg/mm³ | 0.1 µg/mm³ | | Sensitivity to Ambient Light | Physically homogeneous | Physically homogeneous | ≥180s | | Radio Opacity | 3mm compared with aluminium wedge | 2.49 mm | ≥1mm Al | {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ | | Fusion Flo SE | Tetric Evoflow K993783 from Ivoclar Predicate Device | Constic K102603 from DMG America Reference Device | Cal LC K212457 from Prevest Denpro Reference Device | | | Micro Instruments from Kavo) | existing or provisional restorations | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Product Code | EBF | EBF | EBF | EJK | | | • Adhesive cementation of Sonic-Sys inlays • Extended fissure sealings in molars and pre- molars • Repair of composite/cerami c veneers • Blocking out of undercuts • Adhesive cementation of ceramic and composite restorations | | | | Indications for Use | Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects). Anterior restorations (Class III & IV). Small posterior restorations | Class V restorations (cervical caries, root erosion, wedge shaped defects) Anterior restorations (Class III and IV) Small posterior restorations Restorative therapy for mini- cavities of all types (preparation with Sonic-Sys | Constic is a light- cured, self-etching, self-adhesive, radiopaque, flowable restorative composite used for many clinical indications such as Class I and Class II restorations, an adhesive liner under composite restorations, as a pit and fissure sealant, or for repairs and modifications to | Cal LC is indicated for use as a cavity liner and pulp capping material It is self adhering and highly filled | Mechanism of Action | Self-adhesive composites rely on the presence of functional monomers (10-MDP) making them able to surpass the use of an adhesive or an acid etching step. MDP has two groups – a methacrylate group, which copolymerizes with other monomers, and a functional phosphate group, separated by a chain of 10 carbons. Due to its chemical structure and hydrophobicity, it forms a stable calcium salt that is more hydrolytically resistant. The flowable composites with functional monomers | Self-adhesive composites rely on the presence of functional monomers (10-MDP) making them able to surpass the use of an adhesive or an acid etching step. MDP has two groups — a methacrylate group, which copolymerizes with other monomers, and a functional phosphate group, separated by a chain of 10 carbons. Due to its chemical structure and hydrophobicity, it forms a stable calcium salt that is more hydrolytically resistant. The flowable composites with functional monomers offer self-etching and | Self-adhesive composites rely on the presence of functional monomers (10-MDP) making them able to surpass the use of an adhesive or an acid etching step. MDP has two groups – a methacrylate group, which copolymerizes with other monomers, and a functional phosphate group, separated by a chain of 10 carbons. Due to its chemical structure and hydrophobicity, it forms a stable calcium salt that is more hydrolytically resistant. The flowable composites with functional monomers | | {13}------------------------------------------------ {14}------------------------------------------------ | | offer self-etching and self-adhesive properties. They are packed in small syringes that allow for easy dispensing with very small gauge needles. This makes them ideal for use in small preparations that would be difficult to fill otherwise. The photosensitive initiator system and a light source are used to activate the light-cure resin, which is delivered as a single paste and can only cure to a depth of 2 to 3mm. | self-adhesive properties. They are packed in small syringes that allow for easy dispensing with very small gauge needles. This makes them ideal for use in small preparations that would be difficult to fill otherwise. The photosensitive initiator system and a light source are used to activate the light- cure resin, which is delivered as a single paste and can only cure to a depth of 2 to 3mm. | offer self-etching and self-adhesive properties. They are packed in small syringes that allow for easy dispensing with very small gauge needles. This makes them ideal for use in small preparations that would be difficult to fill otherwise. The photosensitive initiator system and a light source are used to activate the light- cure resin, which is delivered as a single paste and can only cure to a depth of 2 to 3mm. | | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Composition | Bisphenol A Glycidyl Methacrylate Ethoxylated Bisphenol A Dimethacrylate Urethane Dimethacrylate Triethylene Glycol Dimethacrylate Silanated Barium Glass Powder Silanated Silica Fumed Silica camphorquinone | Ba-Al-silicate glass Copolymer Mixed oxide Ytterbium Trifluoride Silicone dioxide | Bisphenol A Glycidyl Methacrylate Ethoxylated Bisphenol A Dimethacrylate Triethylene Glycol Dimethacrylate Barium glass in BIS GMA resin matrix from dental resins. Fillers Pigments 10-MDP | Urethane Dimethacrylate Triethylene Glycol Dimethacrylate Silanated Barium Borosilicate Glass Powder Silanated Amorphous Silica Calcium Hydroxide Barium sulphate DL | | | • Ethyl 4-(dimethyl amino benzoate) • 2-Dimethyl ethyl metha acrylate • Butylated Hydroxy Toluene • 10–MDP • Titanium Dioxide • Iron Oxide | | | Camphorquin one • 2-Dimethyl Amino Ethyl Methacrylate • Ethyl4Dimethyl Amino Benzoate • Butylated Hydroxy Toluene. | | Applicable Standards | ISO 4049, 13116:2014 | ISO 4049 | ISO 4049 | ISO 4049, ISO 9917-2 | | Flexural Strength | ≥ 80 MPa | 114 MPa | Complies with ISO 4049 | 96.3 MPa | | Light Intensity (mW/cm²) And Curing Time (sec) | 750 40 1200 20 | ≥500 10 | >400 20 | | | Wavelength for Curing (nm) | 400-450 | 400-500 | 450 | | | Depth of Cure | 1.00 mm (opaque) / 1.5 mm (others) minimum | ≥1.5mm dentin and bleach XL ≥2mm other shades | Complies with ISO 4049 | Complies with ISO 4049 | | Filler particle size (μ) | 2 | 1…