(248 days)
No
The document describes dental restorative materials and their physical properties, with no mention of AI or ML capabilities.
No
The devices are restorative materials used for filling and repairing teeth, which are not considered therapeutic in the context of treating a disease or disorder with a specific therapy. They serve as prosthetics or replacements for lost tooth structure.
No
The provided text clearly states that these devices are used as restorative and filling materials for teeth, indicating they are treatment devices, not diagnostic ones.
No
The device description clearly indicates that these are physical dental restorative materials (composites) supplied in various forms (auto-mix delivery system, flowable composite, etc.), not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses described are for direct application within the patient's mouth for dental restorations, core build-ups, and sealants. This is a therapeutic or restorative purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The descriptions detail materials used for filling cavities and building up tooth structure. These are physical materials applied directly to the anatomical site (teeth).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents for testing, or providing diagnostic information. The performance studies focus on material properties relevant to dental restorations (strength, setting time, radio-opacity, etc.), not analytical performance related to biological specimens.
Therefore, these devices fall under the category of dental restorative materials, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Opallis K201707, Build-it Total Core K102703, Tetric Evoflow K993783, Constic K102603
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
everX Posterior K153127, Cal LC K212457, Tetric Evoceram K042819, Opallis Flow K201707, Evadyne K111666
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 |
- Core build up material on vital and non-vital teeth
- Sealing root canal openings,
- Cavity floor liner,
- Post cementation,
- Restorative material
- 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
- Core build up material on vital and non-vital teeth
- Sealing root canal openings,
- Cavity floor liner,
- Post cementation,
- Restorative material
- Dentin replacement material. | Build-it Total Core is indicated for use as
- Core build up material on vital and non-vital teeth
- Sealing root canal openings,
- Cavity floor liner,
- Post cementation,
- Restorative material
- 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 | 0.02-2.3 | 0.3-10 |
| Filler loading (% Volume) | 68 | 61 | 43 | 45.8 |
| Water Sorption | 400 20 | | |
| Wavelengt
h 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 FGM
Dental Group | Tetric Evoceram
K042819 from | Mechanism of
Action | Dental composites, also
known as resin-based
composites, are a blend
of polymeric matrix with
a dispersion of glass,
mineral or resin filler
particles and/or short
fibers. The filler particles
and/or fibers are mixed
with the matrix using
coupling agents. Dental
composites are applied
to replace tooth
structures that have
been damaged or
destroyed due to caries
or other diseases.
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. | Dental composites, also
known as resin-based
composites, are a blend of
polymeric matrix with a
dispersion of glass, mineral
or resin filler particles
and/or short fibers. The
filler particles and/or fibers
are mixed with the matrix
using coupling agents.
Dental composites are
applied to replace tooth
structures that have been
damaged or destroyed due
to caries or other diseases.
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. | Dental composites,
also known as resin-
based composites,
are a blend of
polymeric matrix
with a dispersion of
glass, mineral or
resin filler particles
and/or short fibers.
The filler particles
and/or fibers are
mixed with the
matrix using
coupling agents.
Dental composites
are applied to
replace tooth
structures that have
been damaged or
destroyed due to
caries or other
diseases.
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. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 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 silicate
silicon dioxide
camphoroquinone | ● Ba-Al-
silicate glass
● Copolymer
● Mixed oxide
● Ytterbium
Trifluoride |
| | | | Reference Device | | | | |
| Product Code | EBF | EBF | EBF | | | | |
| Indications for Use | Magma NT is indicated
for
-direct restoration in
anterior and posterior
teeth Classes I, II, III, IV
and V
-porcelain/composite
repairs. | The composite is suitable
for use in permanent and
deciduous teeth:
-Direct restorations
in
anterior and posterior teeth
Classes I, II, III, IV, V and VI.
-Direct veneers
with
composites.
-Cementation of
tooth
fragments.
- Core build-ups.
-Teeth splinting.
-Diastema closing or
reduction.
-Modification of teeth's
shape (e.g.: conoid teeth).
-Porcelain/composite
repairs | • Anterior
restorations
(Class III and IV)
• Class V
restorations
(cervical caries,
root erosion,
wedge shaped
defects)
• Restorations
in the posterior
region (Class I
and II)
• Veneering
of discolored
anterior teeth
• Splinting of
mobile teeth
• Repair of
composites and
ceramic veneers | | | | |
20
21
| | Camphorquinone Butylated
hydroxy toluene
(BHT) 2-dimethyl
amino ethyl
Methyacrylate Ethyl-4 Di methyl
amino benzoate Titanium Dioxide Iron oxide | accelerators stabilizers and
pigments | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------|
| Applicable
Standards | 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 40
750 20
1200 10 | ≥450 20-60 | ≥500 10 |
| Wavelength for
Curing (nm) | 400-450 | 400-500 | 400-500 |
| Depth of Cure | 2.59 mm (opaque) / 2.89
mm (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 7.5
µm/mm³ | 5.53 µg/mm³ |