(121 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical application of a dental composite, with no mention of AI or ML.
Yes
The device is a dental restorative material used to repair and build up teeth, which falls under the definition of a therapeutic device as it directly treats a medical condition (damaged teeth).
No
The device description and intended use clearly state that SimpliShade Bulk Fill and Bulk Fill Flow are direct restorative materials for dental applications (fillings, core build-ups, sealants, etc.), not devices used for diagnosis.
No
The device description clearly states it is a resin-based dental restorative material, which is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for direct placement of dental restorations, core build-ups, repair of defects, base/liner, pit and fissure sealant, and blocking out undercuts. These are all procedures performed directly on the patient's teeth.
- Device Description: The device is described as an "intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative." This confirms it's a material used within the mouth for restorative purposes.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are used to test samples like blood, urine, tissue, etc., to diagnose diseases or conditions.
- Anatomical Site: The anatomical site is "Oral, teeth," which aligns with a dental restorative material, not an IVD.
Therefore, the SimpliShade Bulk Fill and SimpliShade Bulk Fill Flow are dental restorative materials, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SimpliShade Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
The SimpliShade Bulk Fill Flow is indicated for:
- Base/liner under Class I and Class II direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.
SimpliShade Bulk Fill:
SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family.
SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.
SimpliShade Bulk Fill Flow:
SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations.
SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental clinics or similar healthcare settings.
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)
Performance bench tests according to ISO 4049 for Dental Polymer-Based Restorative Materials have been conducted to determine conformance in regards of flexural strength, sensitivity to light, water sorption, water solubility, depth of cure, radio-opacity, and color stability etc. Additional tests such as compressive strength, diametral tensile strength, rockwell hardness, and volumetric shrinkage, wear, and shrinkage stress have been performed to compare the subject devices and predicate devices. The data from these tests demonstrate that the subject devices SimpliShade Bulk Fill and SimpliShade Bulk Fill Flow are substantially equivalent to the predicate devices 3M Filtek One Bulk Fill Restorative and 3M Filtek Bulk Fill Flowable Restorative.
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.
Filtek™ One Bulk Fill Restorative (K163207), Filtek™ Bulk Fill Flowable Restorative (K120453)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
August 31, 2022
Kerr Corporation Haiyan Wei Senior Regulatory Affairs Specialist 1889 W Mission Blvd Pomona, California 91766
Re: K221255
Trade/Device Name: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 5, 2022 Received: August 5, 2022
Dear Haiyan Wei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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).
Sincerely,
For Michael E. Adjodha, M. ChE. 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
2
Indications for Use
510(k) Number (if known) K221255
Device Name
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Indications for Use (Describe)
The SimpliShade Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
The SimpliShade Bulk Fill Flow is indicated for:
- Base/liner under Class I and Class II direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "Kerr" in a bold, blue font. The word is written in all lowercase letters, except for the "K", which is capitalized. There is a trademark symbol to the right of the second "r" in the word. The background of the image is white.
K221255 - 510(k) Summary
for
SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow
1. Submitter Information:
Kerr Corporation 1889 W Mission Blvd Pomona, CA 91766 USA
| Contact Person: | Haiyan Wei |
|---|---|
| Telephone Number: | (714) 516-7710 |
| Email: | haiyan.wei@kavokerr.com |
June 27, 2022 Date Prepared:
2. Device Name:
| Proprietary Name: | SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow |
|---|---|
| Manufacturer: | Kerr Corporation |
| Common Name: | Tooth Shade Resin Material Restorative |
| Classification Name: | Tooth Shade Resin Material |
| CFR Number: | 872.3690 |
| Device Class: | II |
| Product Code: | EBF |
3. Predicate Device (Primary):
| Proprietary Name: | Filtek™ One Bulk Fill Restorative (K163207) |
|---|---|
| Manufacturer: | 3M ESPE Dental Products |
| Common Name: | Tooth Shade Resin Material Restorative |
| Classification Name: | Tooth Shade Resin Material |
| CFR Number: | 872.3690 |
| Device Class: | II |
| Product Code: | EBF |
Predicate Device #2:
| Proprietary Name: | Filtek™ Bulk Fill Flowable Restorative (K120453) |
|---|---|
| Manufacturer: | 3M ESPE Dental Products |
| Common Name: | Tooth Shade Resin Material |
| Classification Name: | Tooth Shade Resin Material |
| CFR Number: | 872.3690 |
| Device Class: | II |
| Product Code: | EBF |
4. Device Description:
SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.
SimpliShade™ Bulk Fill:
4
Image /page/4/Picture/0 description: The image shows the logo for Kerr, a dental equipment and supplies manufacturer. The logo is in blue and features the company name in a bold, sans-serif font. A trademark symbol is located to the right of the company name. The logo is simple and modern, and the blue color gives it a professional look.
SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family.
SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.
SimpliShade™ Bulk Fill Flow:
SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations.
SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
న్. Principle of Operation / Mechanism of Action:
SimpliShade™ Bulk Fill:
SimpliShade Bulk Fill is a high viscosity resin-based nano-hybrid dental restorative that can be lightcured. It is designed to be used after placement of a dental adhesive. Once the bonding procedure is completed, a liner using a low viscosity flowable composite may optionally be placed and light cured according to the manufacturer's instructions prior to placing SimpliShade Bulk Fill. SimpliShade Bulk Fill is intended to be cured by exposure to light waves with a minimum light intensity of 650 mW/cm² and a light wavelength output within the 400-520 nm range, in incremental layers up to 5 mm. The handling behavior of the material is achieved through the addition of a proprietary rheology modifier as well as an optimized balance of the concentration of the filler system with the resin concentration. When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
SimpliShade™ Bulk Fill Flow:
SimpliShade Bulk Fill Flow is a low viscosity resin-based nano-hybrid dental restorative that can be light-cured. It is designed to be used after placement of a dental adhesive. Once the bonding procedure is completed, a layer of SimpliShade Bulk Fill Flow is placed directly onto the prepared site along the axial and gingival margins. With a brushing action, the material can flow into the marginal interfaces and recesses of the preparation in up to 4mm increments; SimpliShade Bulk Fill Flow is intended to be cured by exposure to light waves with a minimum light intensity of 650 mW/cm² and a light wavelength output within the 400-520 nm range. The handling behavior of the material is achieved through the addition of a proprietary rheology modifier as well as an optimized balance of the concentration of the filler system with the resin concentration. When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
6. Indications for Use:
5
Image /page/5/Picture/0 description: The image shows the word "Kerr" in a bold, blue font. The letters are large and spaced closely together. A small trademark symbol is located to the upper right of the word.
SimpliShade™ Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
SimpliShade™ Bulk Fill Flow is indicated for:
- Base/liner under direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
7. Description of Substantial Equivalence:
The similarities between the SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow (Subject Device) and the Primary Predicate Device Filtek™ One Bulk Fill Restorative (K163207), Predicate Device #2 Filtek™ Bulk Fill Flowable Restorative (K120453), include the Regulatory Classification, Intended Use of the device, Indications for Use, Mode of Action, Device description, and Clinical condition of use. Furthermore, Technological Characteristics and Performance testing including Biocompatibility testing are similar.
There are no major differences but only minor differences between the SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow (Subject Device) and the Primary Predicate Device Filtek™ One Bulk Fill Restorative (K163207), Predicate Device #2 Filtek™ Bulk Fill Flowable Restorative (K120453). The formulation composition slightly varies and performance test results have slightly different values; however, these minor differences have no impact on the device performances which demonstrate subject devices are substantially equivalent as predicate devices.
Table 1 below compares the SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow (Subject Devices) and the Primary Predicate Device Filtek™ One Bulk Fill Restorative (K163207), Predicate Device #2 Filtek™ Bulk Fill Flowable Restorative (K120453) with respect to intended use, technological characteristics and performance testing.
| Descriptive
Information | Subject Device 1 | Subject Device 2 | Predicate Device
(Primary) | Predicte
Device #2 | Comparison |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | SimpliShade™
Bulk Fill
(K221255) | SimpliShade™
Bulk Fill Flow
(K221255) | Filtek™ One Bulk
Fill Restorative
(K163207) | Filtek™ Bulk Fill
Flowable Restorative
(K120453) | |
| Manufacturer | Kerr Corporation | Kerr Corporation | 3M ESPE
Dental Products | 3M ESPE
Dental Products | N/A |
| Regulatory Classification | | | | | |
| Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 | 21 CFR 872.3690 | 21 CFR 872.3690 | Same as
Predicates. |
| Regulation
Title | Tooth Shade Resin
Material | Tooth Shade Resin
Material | Tooth Shade Resin
Material | Tooth Shade Resin
Material | Same as
Predicates. |
| Regulation
Class | Class II | Class II | Class II | Class II | Same as
Predicates. |
| Product Code | EBF | EBF | EBF | EBF | Same as
Predicates. |
| Indications for Use/Intended Use | | | | | |
| Intended Use | Material, Tooth
Shade, Resin | Material, Tooth
Shade, Resin | Material, Tooth
Shade, Resin | Material, Tooth
Shade, Resin | Same as
Predicates. |
| Indications
for Use | 1.Direct placement
of anterior and
posterior
restorations.
2.Core build-ups.
3.Repair of defects
in restorations. | 1.Base/liner under
direct restorations.
2.Pit and fissure
sealant.
3.Restoration of
small cavities.
4.Class III and V
restorations.
5.Blocking out
undercuts.
6.Small core build-
ups.
7.Repair of resin
and acrylic
provisional
restorations. | 1.Direct anterior
and posterior
restorations
(including occlusal
surfaces).
2.Base/liner under
direct restorations.
3.Core build-ups.
4.Splinting.
5.Indirect
restorations
including inlays,
onlays and veneers.
6.Restorations of
deciduous teeth.
7.Extended fissure
sealing in molars
and premolars.
8.Repair of defects
in porcelain
restorations,
enamel, and
temporaries. | 1.Base under Class I
and II direct
restorations.
2.Liner under direct
restorative materials.
3.Pit and fissure
sealant.
4.Restoration of
minimally invasive
cavity preparations
(including small, non
stress-bearing
occlusal restorations).
5.Class III and V
restorations.
6.Undercut blockout.
7.Repair of small
enamel defects.
8.Repair of small
defects in esthetic
indirect restorations.
9.Repair of resin and
acrylic temporary
materials.
10.As a core build-up
where at least half the
coronal tooth
structure is remaining
to provide structural
support for the
crown. | Same
Indication for
Use as
Predicate
Devices and
expressed
through
similar choice
of wording. |
| Technological Characteristics | | | | | |
| Clinical
condition of
use | Dental clinics or
similar healthcare
settings. | Dental clinics or
similar healthcare
settings. | Dental clinics or
similar healthcare
settings. | Dental clinics or
similar healthcare
settings. | Same as
Predicate
Devices. |
| Anatomical
location of
use | Oral, teeth | Oral, teeth | Oral, teeth | Oral, teeth | Same as
Predicate
Devices. |
| Principles of
Operation | Tooth shade resin-
based dental
restorative that can
be light-cured by | Tooth shade resin-
based dental
restorative that can
be light-cured by | Tooth shade resin-
based dental
restorative that can
be light-cured by | Tooth shade resin-
based dental
restorative that can
be light-cured by | Same as
Predicate
Devices. |
| | photo
polymerization. | photo
polymerization. | photo
polymerization. | photo
polymerization. | |
| Storage | Store at room
temperature 2-28°C
(36-82°F). | Store at room
temperature 2-28°C
(36-82°F). | Store at room
temperature 2-
27°C. | Store at room
temperature 2-27°C. | Similar to
Predicate
devices. |
| Compatible
with
methacrylate-
based dental
adhesives | Yes | Yes | Yes | Yes | Same as
Predicate
Devices. |
| Recommende
d for load-
bearing
occlusal
surfaces | Yes | No | Yes | No | Same as
Predicate
Devices. |
| Primary
Packaging | Syringe and
Capsule | Syringe and
Capsule | Syringe and
Capsule | Syringe and Capsule | Same as
Predicate
Devices. |
| Material
Composition | Methacrylate
resins, Photo-
initiators,
Inorganic fillers | Methacrylate
resins, Photo-
initiators,
Inorganic fillers | Methacrylate
resins, Photo-
initiators,
Inorganic fillers | Methacrylate resins,
Photo-initiators,
Inorganic fillers | Similar to
Predicate
devices. |
| Containing
Inorganic
Fillers | Yes | Yes | Yes | Yes | Same as
Predicate
Devices. |
| Primary
Filler particle
size range | 40 nm - 0.4 µm | 40 nm - 0.1 µm | 4 nm - 100 nm | 10 nm - 5.0 µm | Similar to
Predicate
devices. |
| Curing
Mechanism | Photo-initiation | Photo-initiation | Photo-initiation | Photo-initiation | Same as
Predicate
Devices. |
| Intensity
(mW/cm²) for
curing | ≥ 650 mW/cm² | ≥ 650 mW/cm² | ≥ 550 mW/cm² | ≥ 550 mW/cm² | Similar to
Predicate
devices. |
| Wavelength
(nm) for
curing | 400 - 520 nm | 400 - 520 nm | 400 - 500 nm | 400 - 500 nm | Similar to
Predicate
Devices. |
| Curing Time
(sec) | 20 sec (≥ 650
mW/cm²) | 20 sec (≥ 650
mW/cm²) | At least 20 sec (≥
550 mW/cm²) | 20 sec (≥ 550
mW/cm²) | Similar to
Predicate
Devices. |
| Depth of
Cure (mm) | Up to 5mm | Up to 4mm | Up to 5mm | Up to 4mm | Similar to
Predicate
Devices. |
| Compressive
Strength
(MPa) | Meet the criteria
per internal
standard | Meet the criteria
per internal
standard | Meet the criteria
per internal
standard | Meet the criteria per
internal standard | Similar to
Predicate
Devices. |
| Internal
standard
260 Mpa | | | | | |
| Rockwell
Hardness
(RHN)
Internal
Standard
65 RHN | Meet the criteria
per internal
standard | Meet the criteria
per internal
standard | Meet the criteria
per internal
standard | Meet the criteria per
internal standard | Similar to
Predicate
Devices. |
| Flexural
Strength
(Mpa) | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO 4049
requirement | Similar to
Predicate
Devices. |
| Radio-opacity
(mm of AI) | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO 4049
requirement | Similar to
Predicate
Devices. |
| Water
Sorption
(µg/mm³) | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO 4049
requirement | Similar to
Predicate
Devices. |
| Water
Solubility
(µg/mm³) | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO 4049
requirement | Similar to
Predicate
Devices. |
| Sensitivity to
ambient light | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO 4049
requirement | Same as
Predicate
Devices. |
| Color
Stability | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO
4049 requirement | Conform to ISO 4049
requirement | Same as
Predicate
Devices. |
| Performance Testing | | | | | |
| Biocompatabi
lity | ISO 10993-1:2018
ISO 10993-3:2014
ISO 10993-5:2009
ISO 10993-6:2016
ISO 10993 10:2021
ISO 10993-
11:2017
ISO 10993-
12:2021
ISO 10993-
23:2021
ISO 7405:2018 | ISO 10993-1:2018
ISO 10993-3:2014
ISO 10993-5:2009
ISO 10993-6:2016
ISO 10993-
10:2010
ISO 10993-
11:2017
ISO 10993-
12:2021
ISO 10993-
23:2021
ISO 7405:2018 | ISO 10993-1:2009
ISO 10993-3:2014
ISO 10993-5:2009
ISO 10993-6:2007
ISO 10993-
10:2010
ISO 10993-
11:2006
ISO 10993-
12:2012
ISO 7405:2008
/AMD1 2013 | ISO 10993-1:2009
ISO 10993-3:2003
ISO 10993-5:2009
ISO 10993-6:2007
ISO 10993-10:2010
ISO 10993-11:2006
ISO 10993-12:2012
ISO 7405:2008 | Similar to
Predicate
devices. |
| Dentistry -
Polymer-
based
restorative
materials | ISO 4049:2019 | ISO 4049:2019 | ISO 4049:2009 | ISO 4049:2009 | Similar to
Predicate
devices. |
Table 1: Device Comparison Table
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- Non-Clinical Test Data:
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Performance bench tests according to ISO 4049 for Dental Polymer-Based Restorative Materials have been conducted to determine conformance in regards of flexural strength, sensitivity to light, water sorption, water solubility, depth of cure, radio-opacity, and color stability etc. Additional tests such as compressive strength, diametral tensile strength, rockwell hardness, and volumetric shrinkage, wear, and shrinkage stress have been performed to compare the subject devices and predicate devices. The data from these tests demonstrate that the subject devices SimpliShade Bulk Fill and SimpliShade Bulk Fill Flow are substantially equivalent to the predicate devices 3M Filtek One Bulk Fill Restorative and 3M Filtek Bulk Fill Flowable Restorative.
9. Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the subject devices.
10. Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the SimpliShade™ Bulk Fill and SimpliShade™ Bulk Fill Flow are deemed to be substantially equivalent to the predicate devices.