(248 days)
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 erosion, 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.
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.
The provided text describes the acceptance criteria and performance of several dental composite resins from Prevest Denpro Limited (Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT) as part of a 510(k) premarket notification to the FDA. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the requirements of ISO 4049:2019 and ISO 13116:2014, with specific values mentioned for some parameters. The reported device performance indicates that "All test results met the criteria in standards."
| Device Property | Acceptance Criteria (Standard / Value) | Reported Device Performance |
|---|---|---|
| Fusion Core DC Flo | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥50 MPa), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (maximum of 40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³), Working Time (1:25), Setting Time (3:20). |
| Fusion Flo | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (1.00 mm opaque / 1.5 mm others minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Fusion Flo SE | Based on ISO 4049:2019 & ISO 13116:2014, USP 971 (for pH) | Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (1.00 mm opaque / 1.5 mm others minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (<40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Fusion I-Seal | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥ 25 MPa), Depth of Cure (1.5 mm minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Magma NT | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (2.59 mm opaque / 2.89 mm non-opaque), Radio Opacity (3mm compared with aluminum wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Shelf Life (all composites) | Testing protocols based on ISO 4049:2019 | Shelf life of 3 years (except Fusion Core DC Flo: 2 years). Determinations use the same testing protocols and met the criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the test sets for each specific test (e.g., flexural strength, water sorption). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Prevest Denpro Limited, is based in India, so it's possible the testing was conducted there, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The "ground truth" for dental composite resins is established through objective physical and chemical testing against international standards (ISO standards), rather than expert interpretation of images or clinical outcomes that require human assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "truth" is determined by objective laboratory measurements against predefined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This study concerns the physical and chemical properties of dental composite resins, not an AI-powered diagnostic device requiring evaluation of human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating these dental composite resins is defined by international standard specifications for physical and chemical properties as outlined in ISO 4049:2019 (Dentistry - Polymer-based restorative materials) and ISO 13116:2014 (Dentistry - Dental impression materials - Radiopacity). For Fusion Flo SE, USP 971 was also referenced for pH testing. The "truth" is whether the measured properties of the device meet the quantitative limits set by these standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no training set or ground truth established in that context.
{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 as1. Core build up material on vital and non-vital teeth2. Sealing root canal openings,3. Cavity floor liner,4. Post cementation,5. Restorative material6. 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 K102703From SybronPredicate Device | everX Posterior K153127 fromGC AmericaReference Device | Cal LC K212457 fromPrevest DenproReference Device | |
|---|---|---|---|---|
| Product Code | EBF | EBF | EJK | EJK |
| Indicationsfor Use | Fusion Core DC Flo is indicated for use as1. Core build up material on vital and non-vital teeth2. Sealing root canal openings,3. Cavity floor liner,4. Post cementation,5. Restorative material6. Dentin replacement material. | Build-it Total Core is indicated for use as1. Core build up material on vital and non-vital teeth2. Sealing root canal openings,3. Cavity floor liner,4. Post cementation,5. Restorative material6. 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. |
| Mechanismof 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 assuranceof complete curingeven in areas thatmay be hard to reachfor the curing light.Curing times varybut are oftencompleted within 5minutes. The dualcured composite atthe top surface ismainly polymerizedthrough photo-initiated chemicalreactions, while atthe bottom surface itis done viachemically initiatedpolymerization. | chemical curingagents. Thisoffers theassurance ofcomplete curingeven in areas thatmay be hard toreach for thecuring light.Curing timesvary but are oftencompleted within5 minutes. Thedual curedcomposite at thetop surface ismainlypolymerizedthrough photo-initiated chemicalreactions, whileat the bottomsurface it is donevia chemicallyinitiatedpolymerization. | |||
| ApplicableStandards | 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}------------------------------------------------
| Butylatedhydroxytoluene(BHT) Fumed Silica Benzoylperoxide YetterbiumFluoride Catalyst: Bisphenol AGlycidylMethacrylate EthoxylatedBisphenol ADimethacrylate TriethyleneGlycolDimethacrylate SilanatedBariumGlassPowder SilanatedFumed Silica Camphorquinone Butylatedhydroxytoluene(BHT) Fumed Silica YetterbiumFluoride Ethyl -4-dimethylaminobenzoate 2-dimethylamino ethylMethyacrylate | sulphate DLCamphorquinone 2-DimethylAmino EthylMethacrylate Ethyl4Dimethyl AminoBenzoate ButylatedHydroxyToluene. | |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | ------------------------------------------------------------------------------------------------------------------------------------------- |
{9}------------------------------------------------
| • Dihydroxy ethyl p-toluidiene• Titanium Dioxide | ||||
|---|---|---|---|---|
| FlexuralStrength | ≥50 MPa | Complies with ISO 4049 | Complies with ISO 4049 | 96.3 MPa |
| LightIntensity(mW/cm²)And CuringTime (sec) | ≤600 40750 201200 10 | ≥600 20 | >1200 10700 20 | |
| Wavelengthfor Curing(nm) | 400-450 | 400-450 | 400-450 | |
| Depth ofCure (mm) | Not applicable | 10mm | 4mm | |
| WorkingTime(min:sec)Dual Cure | 1:25 | |||
| Setting Time(min:sec)Dual Cure | 3:20 | |||
| Filler particlesize (μ) | 2 | 0.3-10 | ||
| Filler loading(% Volume) | 65 | 45.8 | ||
| RadioOpacity | 3mm comparedwith aluminiumwedge | Complies with ISO 4049,13116:2014 | Complies with ISO 4049 | Complies with ISO13116:2014 |
| WaterSorption | maximum of 40µg/mm3 | Complies with ISO 4049 | Complies with ISO 4049 | Complies with ISO4049 |
| WaterSolubility | maximum of 7.5um/mm³ | 1 g/L | Complies with ISO 4049 | Complies with ISO4049 |
| Fusion Flo | Opallis Flow K201707 fromFGM Dental GroupReference Device | Tetric EvoflowK993783 from IvoclarPredicate Device | |
|---|---|---|---|
| Product Code | EBF | EBF | EBF |
| Indications for Use | Fusion Flo is indicated fordirect filling of | Base/lining underneathdirect restorations.- Small, non-occlusal stress-bearing class I restorations | • Class Vrestorations(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 bedifficult to fill otherwise.The photosensitive initiatorsystem and a light sourceare used to activate thelight-cure resin, which isdelivered as a single pasteand can only cure to a depthof 2 to 3mm. | preparations that would bedifficult to fill otherwise.The photosensitive initiatorsystem and a light sourceare used to activate thelight-cure resin, which isdelivered as a single pasteand can only cure to adepth of 2 to 3mm. | easy dispensing withvery small gaugeneedles. This makesthem ideal for use insmall preparations thatwould be difficult to fillotherwise.The photosensitiveinitiator systemand a light sourceare used toactivate the light-cure resin, which isdelivered as asingle paste andcan only cure to adepth of 2 to3mm. | |
| Composition | ● Bisphenol A GlycidylMethacrylate● EthoxylatedBisphenol ADimethacrylate● UrethaneDimethacrylate● Triethylene GlycolDimethacrylate● Barium GlassPowder● Fumed Silica● Silanated● Amorphous Silica● camphorquinone● Ethyl 4-( dimethylamino benzoate)● 2-Dimethylethylmethaacrylate● Butylated HydroxyToluene● Titanium Dioxide● Iron oxide | ● Bisphenol AGlycidylMethacrylate● EthoxylatedBisphenol ADimethacrylate● UrethaneDimethacrylate● Triethylene GlycolDimethacrylate● Fillers: Barium-Aluminum,silanized● Silicate● silicon dioxide● camphoroquinone● accelerators● stabilizers andpigments. | ● Ba-Al-silicateglass● Copolymer● Mixed oxide● YtterbiumTrifluoride● Siliconedioxide |
| ApplicableStandards | ISO 4049, 13116:2014 | ISO 4049 | ISO 4049 |
| FlexuralStrength | ≥ 80 MPa | 137.80 MPa | 114 MPa |
| Light Intensity(mW/cm²)And CuringTime (sec) | ≤600 40750 201200 10 | ≥500 40 | ≥500 10 |
| Wavelengthfor Curing (nm) | 400-450 | 400-500 | 400-500 |
| Depth of Cure | 1.00 mm (opaque) / 1.5 mm(others) minimum | ≤2mm | ≥1.5mm dentin andbleach XL≥2mm other shades |
| Filler particlesize (μ) | 1 | 0.05-5 | 1 |
| Filler loading(% Volume) | 62 | 72 | 61 |
| WaterSorption | ≤40 µg/mm3 | 27.92 µg/mm³ | 21.0 µg/mm³ |
| WaterSolubility | maximum of 7.5 µm/mm³ | 5.46 µg/mm³ | 0.1 µg/mm³ |
| Sensitivity toAmbient Light | Physically homogeneous | Physically homogeneous | ≥180s |
| Radio Opacity | 3mm compared withaluminium wedge | 2.49 mm | ≥1mm Al |
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
| Fusion Flo SE | Tetric EvoflowK993783 from IvoclarPredicate Device | Constic K102603from DMG AmericaReference Device | Cal LC K212457 fromPrevest DenproReference Device | Micro Instrumentsfrom Kavo) | existing orprovisionalrestorations | ||||
|---|---|---|---|---|---|---|---|---|---|
| ProductCode | EBF | EBF | EBF | EJK | • Adhesivecementation ofSonic-Sys inlays• Extendedfissure sealings inmolars and pre-molars• Repair ofcomposite/ceramic veneers• Blocking outof undercuts• Adhesivecementation ofceramic andcompositerestorations | ||||
| Indicationsfor Use | Fusion Flo SE isindicated for directfilling of class V(cervicalcaries, rooterosion,wedgeshapeddefects). Anteriorrestorations(Class III &IV). Smallposteriorrestorations | Class Vrestorations(cervical caries,root erosion,wedge shapeddefects) Anteriorrestorations (ClassIII and IV) Smallposteriorrestorations Restorativetherapy for mini-cavities of alltypes (preparationwith Sonic-Sys | Constic is a light-cured, self-etching,self-adhesive,radiopaque,flowable restorativecomposite used formany clinicalindications such asClass I and Class IIrestorations, anadhesive linerunder compositerestorations, as a pitand fissure sealant,or for repairs andmodifications to | Cal LC is indicatedfor use as a cavityliner and pulpcapping material It isself adhering andhighly filled | Mechanismof Action | Self-adhesivecomposites rely onthe presence offunctional monomers(10-MDP) makingthem able to surpassthe use of anadhesive or an acidetching step. MDPhas two groups – amethacrylate group,which copolymerizeswith othermonomers, and afunctional phosphategroup, separated bya chain of 10carbons. Due to itschemical structureand hydrophobicity,it forms a stablecalcium salt that ismore hydrolyticallyresistant.The flowablecomposites withfunctional monomers | Self-adhesivecomposites rely onthe presence offunctional monomers(10-MDP) makingthem able to surpassthe use of an adhesiveor an acid etchingstep. MDP has twogroups — amethacrylate group,which copolymerizeswith other monomers,and a functionalphosphate group,separated by a chainof 10 carbons. Due toits chemical structureand hydrophobicity, itforms a stable calciumsalt that is morehydrolyticallyresistant.The flowablecomposites withfunctional monomersoffer self-etching and | Self-adhesivecomposites rely onthe presence offunctional monomers(10-MDP) makingthem able to surpassthe use of anadhesive or an acidetching step. MDPhas two groups – amethacrylate group,which copolymerizeswith othermonomers, and afunctional phosphategroup, separated bya chain of 10carbons. Due to itschemical structureand hydrophobicity,it forms a stablecalcium salt that ismore hydrolyticallyresistant.The flowablecomposites withfunctional monomers |
{13}------------------------------------------------
{14}------------------------------------------------
| offer self-etching andself-adhesiveproperties. They arepacked in smallsyringes that allowfor easy dispensingwith very small gaugeneedles. This makesthem ideal for use insmall preparationsthat would bedifficult to fillotherwise.The photosensitiveinitiator system anda light source areused to activate thelight-cure resin,which is deliveredas a single pasteand can only cureto a depth of 2 to3mm. | self-adhesiveproperties. They arepacked in smallsyringes that allow foreasy dispensing withvery small gaugeneedles. This makesthem ideal for use insmall preparationsthat would be difficultto fill otherwise.The photosensitiveinitiator system and alight source are usedto activate the light-cure resin, which isdelivered as a singlepaste and can onlycure to a depth of 2 to3mm. | offer self-etching andself-adhesiveproperties.They are packed insmall syringes thatallow for easydispensing with verysmall gauge needles.This makes themideal for use in smallpreparations thatwould be difficult tofill otherwise.The photosensitiveinitiator system and alight source are usedto activate the light-cure resin, which isdelivered as a singlepaste and can onlycure to a depth of 2to 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 401200 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 | 0.02-2.3 | 0.3-10 |
| Filler loading (% Volume) | 68 | 61 | 43 | 45.8 |
| Water Sorption | <40 µg/mm3 | 21.0 µg/mm³ | Complies with ISO 4049 | Complies with ISO 4049 |
| Water Solubility | maximum of 7.5 μm/mm³ | 0.1 µg/mm³ | 1 g/L | Complies with ISO 4049 |
| Sensitivity to Ambient Light | Physically homogeneous | ≥180s | Physically homogeneous | |
| Radio Opacity | 3mm compared with aluminium wedge | ≥1mm Al | Complies with ISO 4049 | Complies with ISO 13116:2014 |
{15}------------------------------------------------
{16}------------------------------------------------
| Fusion I Seal | Constic K102603from DMGAmericaPredicate Device | Evadyne K111666from NeodentReference Device | Cal LC K212457 fromPrevest DenproReference Device | |
|---|---|---|---|---|
| ProductCode | EBF | EBF | EBG | EJK |
| Indications for Use | Fusion I-Seal isindicated for Class Iand Class IIrestorations, as aliner undercompositerestorations, and as apit and fissuresealant. | Constic is alight-cured,self-etching,self-adhesive,radiopaque,flowablerestorativecomposite usedfor manyclinicalindicationssuch as Class Iand Class IIrestorations, anadhesive linerundercompositerestorations, asa pit and fissuresealant, or forrepairs andmodificationsto existing orprovisionalrestorations | Evadyne is a lightcured single-componentmaterial for thetemporaryrestoration ofcrowns, bridges, orsimilar dentalprostheses.Evadyne isintended for thegeneral dentalpatient population. | Cal LC is indicatedfor use as a cavityliner and pulpcapping material. Itis self-adhering andhighly filled |
| Mechanism ofAction | Glass fillerfluoroaluminosilicatecomposites are filledcomposites whichare flowable andhave physical andmechanicalproperties whichinclude the releaseof fluoride.The flowablecomposites arepacked in smallsyringes that allow | Self-adhesivecomposites relyon the presenceof functionalmonomers (10-MDP) makingthem able tosurpass the useof an adhesive oran acid etchingstep. MDP hastwo groups – amethacrylategroup, whichcopolymerizes | Glass fillerfluoroaluminosilicate composites arefilled compositeswhich are flowableand have physicaland mechanicalproperties whichinclude the releaseof fluoride.The flowablecomposites arepacked in smallsyringes that allow |
{17}------------------------------------------------
| with very small | monomers, and | with very small |
|---|---|---|
| gauge needles. Thismakes them ideal foruse in smallpreparations thatwould be difficult tofill otherwise. | a functionalphosphategroup, separatedby a chain of 10carbons. Due toits chemicalstructure andhydrophobicity,it forms a stablecalcium salt thatis morehydrolyticallyresistant. | gauge needles. Thismakes them idealfor use in smallpreparations thatwould be difficultto fill otherwise. |
| The photosensitiveinitiator system anda light source areused to activate thelight-cure resin,which is deliveredas a single pasteand can only cureto a depth of 2 to3mm. | The flowablecomposites withfunctionalmonomers offerself-etching andself-adhesiveproperties.They are packedin small syringesthat allow foreasy dispensingwith very smallgauge needles.This makes themideal for use insmallpreparationsthat would bedifficult to fillotherwise. | Thephotosensitiveinitiator systemand a light sourceare used toactivate the light-cure resin, whichis delivered as asingle paste andcan only cure to adepth of 2 to3mm. |
{18}------------------------------------------------
| a depth of 2 to3mm. | ||||
|---|---|---|---|---|
| Composition | Bisphenol AGlycidylMethacrylate UrethaneDimethacrylate SilanatedBarium GlassPowder BariumSulphate FluoroAlumino silicateGlass Powder Silanatedfumed Silica camphorquinone Ethyl 4-(dimethylaminobenzoate) 2-Dimethylethyl methaacrylate ButylatedHydroxyToluene | Bisphenol AGlycidylMethacrylate EthoxylatedBisphenol ADimethacrylate TriethyleneGlycolDimethacrylate Bariumglass in BISGMA resinmatrix fromdentalresins. Fillers Pigments 10-MDP | Bisphenol AGlycidylMethacrylate UrethaneDimethacrylate FluoroAlumino silicateGlass Ethyl 4-(dimethylaminobenzoate) Pigments Additives Catalyst InorganicfillerParticles | UrethaneDimethacrylate TriethyleneGlycolDimethacrylate SilanatedBariumBorosilicateGlass Powder SilanatedAmorphousSilica CalciumHydroxide Bariumsulphate DLCamphorquinone 2-DimethylAmino EthylMethacrylate Ethyl4Dimethyl AminoBenzoate ButylatedHydroxyToluene. |
| ApplicableStandards | ISO 4049,13116:2014 | ISO 4049 | ISO 4049, ISO10477 | ISO 4049 , ISO 9917-2 |
| FlexuralStrength | $\geq$ 25 MPa | Complies withISO 4049 | Complies with ISO4049 | 96.3 MPa |
| LightIntensity(mW/cm2)AndCuringTime (sec) | $\leq$ 600 40750 401200 10 | >400 20 | ||
| Wavelength for | 400-450 | 450 | ||
| Curing (nm) | ||||
| Depth of Cure | 1.5 mm minimum | Complies with ISO 4049 | Complies with ISO 4049 | Complies with ISO 4049 |
| Filler particle size (μ) | 5 | 0.02-2.3 | 0.3-10 | |
| Filler loading (% Volume) | 40 | 43 | 45.8 | |
| Water Sorption | ≤40 µg/mm3 | Complies with ISO 4049 | Complies with ISO 4049 | |
| Water Solubility | maximum of 7.5 µm/mm³ | 1g/L | Complies with ISO 4049 | |
| Radio Opacity | 3mm compared with aluminium wedge | Complies with ISO 4049 | Complies with ISO 13116:2014 |
{19}------------------------------------------------
| Magma NT | Opallis K201707 from FGMDental Group | Tetric EvoceramK042819 from | Mechanism ofAction | Dental composites, alsoknown as resin-basedcomposites, are a blendof polymeric matrix witha dispersion of glass,mineral or resin fillerparticles and/or shortfibers. The filler particlesand/or fibers are mixedwith the matrix usingcoupling agents. Dentalcomposites are appliedto replace toothstructures that havebeen damaged ordestroyed due to cariesor other diseases.The photosensitiveinitiator system and alight source are used toactivate the light-cureresin, which isdelivered as a singlepaste and can only cureto a depth of 2 to 3mm. | Dental composites, alsoknown as resin-basedcomposites, are a blend ofpolymeric matrix with adispersion of glass, mineralor resin filler particlesand/or short fibers. Thefiller particles and/or fibersare mixed with the matrixusing coupling agents.Dental composites areapplied to replace toothstructures that have beendamaged or destroyed dueto caries or other diseases.The photosensitiveinitiator system and alight source are used toactivate the light-cureresin, which is deliveredas a single paste and canonly cure to a depth of 2to 3mm. | Dental composites,also known as resin-based composites,are a blend ofpolymeric matrixwith a dispersion ofglass, mineral orresin filler particlesand/or short fibers.The filler particlesand/or fibers aremixed with thematrix usingcoupling agents.Dental compositesare applied toreplace toothstructures that havebeen damaged ordestroyed due tocaries or otherdiseases.The photosensitiveinitiator system anda light source areused to activate thelight-cure resin,which is delivered asa single paste andcan only cure to adepth of 2 to 3mm. | |
|---|---|---|---|---|---|---|---|
| Predicate Device | Ivoclar | Composition | ● Bisphenol A● Glycidyl● Methacrylate● Ethoxylated● Bisphenol A● Dimethacrylate● Urethane● Dimethacrylate● Triethylene● Glycol● Dimethacrylate● Silanated Barium● Glass Powder● Amorphous● Fumed Silica | ● Bisphenol A● Glycidyl● Methacrylate● Ethoxylated● Bisphenol A● Dimethacrylate● Urethane● Dimethacrylate● Triethylene Glycol● Dimethacrylate● Fillers: Barium-Aluminum,silanized silicatesilicon dioxidecamphoroquinone | ● Ba-Al-silicate glass● Copolymer● Mixed oxide● YtterbiumTrifluoride | ||
| Reference Device | |||||||
| Product Code | EBF | EBF | EBF | ||||
| Indications for Use | Magma NT is indicatedfor-direct restoration inanterior and posteriorteeth Classes I, II, III, IVand V-porcelain/compositerepairs. | The composite is suitablefor use in permanent anddeciduous teeth:-Direct restorationsinanterior and posterior teethClasses I, II, III, IV, V and VI.-Direct veneerswithcomposites.-Cementation oftoothfragments.- Core build-ups.-Teeth splinting.-Diastema closing orreduction.-Modification of teeth'sshape (e.g.: conoid teeth).-Porcelain/compositerepairs | • Anteriorrestorations(Class III and IV)• Class Vrestorations(cervical caries,root erosion,wedge shapeddefects)• Restorationsin the posteriorregion (Class Iand II)• Veneeringof discoloredanterior teeth• Splinting ofmobile teeth• Repair ofcomposites andceramic veneers |
{20}------------------------------------------------
{21}------------------------------------------------
| Camphorquinone Butylatedhydroxy toluene(BHT) 2-dimethylamino ethylMethyacrylate Ethyl-4 Di methylamino benzoate Titanium Dioxide Iron oxide | accelerators stabilizers andpigments | ||
|---|---|---|---|
| ApplicableStandards | ISO 4049, 13116:2014 | ISO 4049 | ISO 4049 |
| Flexural Strength | ≥ 80 MPa | 93.38 MPa | 120 MPa |
| Light Intensity(mW/cm²)And Curing Time(sec) | ≤600 40750 201200 10 | ≥450 20-60 | ≥500 10 |
| Wavelength forCuring (nm) | 400-450 | 400-500 | 400-500 |
| Depth of Cure | 2.59 mm (opaque) / 2.89mm (non-opaque) | ≤1.5mm | ≥1.5mm dentin≥2mm other shades |
| Filler particle size (μ) | 2 | 0.04-3 | 1 |
| Filler loading (%Volume) | 10 | 57.5 | 79 |
| Water Sorption | ≤40 µg/mm³ | 28.93 µg/mm³ | 21.2 µg/mm³ |
| Water Solubility | maximum of 7.5µm/mm³ | 5.53 µg/mm³ | <1.0 µg/mm³ |
| Sensitivity toAmbient Light | Physically homogeneous | Physically homogeneous | ≥180s |
| Radio Opacity | 3mm compared withaluminum wedge | 2.46 mm | ≥1mm Al |
Conclusion: Prevest Denpro composites are substantially equivalent to the predicate devices Opalis and Opalis Flow K201707. They have the same indications, the same wavelength for curing times, similar testing, and very similar ingredients. Curing times are all within 10-40 secs for both the subject devices and predicate devices so similar enough that the differences would not be noticed when treating a patient. Both the subject devices and the predicate device have physical parameters which meet requirements of the relevant ISO standards. Shelf life testing is similar to the shelf life testing of predicate or reference device. Reference devices are included to cover any ingredients, or indications not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.