SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Device Facts
| Record ID | K221255 |
|---|---|
| Device Name | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow |
| Applicant | Kerr Corporation |
| Product Code | EBF · Dental |
| Decision Date | Aug 31, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
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.
Device Story
SimpliShade Bulk Fill and Bulk Fill Flow are light-cured, resin-based nanohybrid dental restoratives. Used in dental clinics by practitioners for direct restorations. SimpliShade Bulk Fill (high viscosity) allows 5mm single-increment placement; SimpliShade Bulk Fill Flow (low viscosity) allows 4mm single-increment placement. Both utilize proprietary rheology modifiers and filler systems. Polymerization occurs via light-induced reaction (400-520 nm, min 650 mW/cm²) of methacrylate resins and fillers. Products are delivered via Unidose compules or syringes. Benefits include optical blending with VITA shade guides and structural support for tooth restoration. Clinical decision-making is supported by the material's physical properties (compressive strength, hardness, radio-opacity) ensuring durable, esthetic outcomes.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, including ISO 4049 compliance (flexural strength, water sorption/solubility, depth of cure, radio-opacity, color stability) and comparative testing (compressive strength, diametral tensile strength, Rockwell hardness, volumetric shrinkage, wear, shrinkage stress).
Technological Characteristics
Resin-based nanohybrid dental restorative; methacrylate resins, photo-initiators, inorganic fillers. Curing: photo-polymerization (400-520 nm, ≥650 mW/cm²). Form factor: Unidose compules or syringes. Standards: ISO 4049:2019, ISO 10993 biocompatibility series. High viscosity (Bulk Fill) and low viscosity (Bulk Fill Flow) variants.
Indications for Use
Indicated for direct anterior/posterior restorations, core build-ups, and repair of defects (SimpliShade Bulk Fill); or as base/liner, pit/fissure sealant, small cavity restoration, Class III/V restorations, undercut blockout, and repair of provisional restorations (SimpliShade Bulk Fill Flow).
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
Predicate Devices
Submission Summary (Full Text)
{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)
### 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."
{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<br>Information | Subject Device 1 | Subject Device 2 | Predicate Device<br>(Primary) | Predicte<br>Device #2 | Comparison |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | SimpliShade™<br>Bulk Fill<br>(K221255) | SimpliShade™<br>Bulk Fill Flow<br>(K221255) | Filtek™ One Bulk<br>Fill Restorative<br>(K163207) | Filtek™ Bulk Fill<br>Flowable Restorative<br>(K120453) | |
| Manufacturer | Kerr Corporation | Kerr Corporation | 3M ESPE<br>Dental Products | 3M ESPE<br>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<br>Predicates. |
| Regulation<br>Title | Tooth Shade Resin<br>Material | Tooth Shade Resin<br>Material | Tooth Shade Resin<br>Material | Tooth Shade Resin<br>Material | Same as<br>Predicates. |
| Regulation<br>Class | Class II | Class II | Class II | Class II | Same as<br>Predicates. |
| Product Code | EBF | EBF | EBF | EBF | Same as<br>Predicates. |
| Indications for Use/Intended Use | | | | | |
| Intended Use | Material, Tooth<br>Shade, Resin | Material, Tooth<br>Shade, Resin | Material, Tooth<br>Shade, Resin | Material, Tooth<br>Shade, Resin | Same as<br>Predicates. |
| Indications<br>for Use | 1.Direct placement<br>of anterior and<br>posterior<br>restorations.<br>2.Core build-ups.<br>3.Repair of defects<br>in restorations. | 1.Base/liner under<br>direct restorations.<br>2.Pit and fissure<br>sealant.<br>3.Restoration of<br>small cavities.<br>4.Class III and V<br>restorations.<br>5.Blocking out<br>undercuts.<br>6.Small core build-<br>ups.<br>7.Repair of resin<br>and acrylic<br>provisional<br>restorations. | 1.Direct anterior<br>and posterior<br>restorations<br>(including occlusal<br>surfaces).<br>2.Base/liner under<br>direct restorations.<br>3.Core build-ups.<br>4.Splinting.<br>5.Indirect<br>restorations<br>including inlays,<br>onlays and veneers.<br>6.Restorations of<br>deciduous teeth.<br>7.Extended fissure<br>sealing in molars<br>and premolars.<br>8.Repair of defects<br>in porcelain<br>restorations,<br>enamel, and<br>temporaries. | 1.Base under Class I<br>and II direct<br>restorations.<br>2.Liner under direct<br>restorative materials.<br>3.Pit and fissure<br>sealant.<br>4.Restoration of<br>minimally invasive<br>cavity preparations<br>(including small, non<br>stress-bearing<br>occlusal restorations).<br>5.Class III and V<br>restorations.<br>6.Undercut blockout.<br>7.Repair of small<br>enamel defects.<br>8.Repair of small<br>defects in esthetic<br>indirect restorations.<br>9.Repair of resin and<br>acrylic temporary<br>materials.<br>10.As a core build-up<br>where at least half the<br>coronal tooth<br>structure is remaining<br>to provide structural<br>support for the<br>crown. | Same<br>Indication for<br>Use as<br>Predicate<br>Devices and<br>expressed<br>through<br>similar choice<br>of wording. |
| Technological Characteristics | | | | | |
| Clinical<br>condition of<br>use | Dental clinics or<br>similar healthcare<br>settings. | Dental clinics or<br>similar healthcare<br>settings. | Dental clinics or<br>similar healthcare<br>settings. | Dental clinics or<br>similar healthcare<br>settings. | Same as<br>Predicate<br>Devices. |
| Anatomical<br>location of<br>use | Oral, teeth | Oral, teeth | Oral, teeth | Oral, teeth | Same as<br>Predicate<br>Devices. |
| Principles of<br>Operation | Tooth shade resin-<br>based dental<br>restorative that can<br>be light-cured by | Tooth shade resin-<br>based dental<br>restorative that can<br>be light-cured by | Tooth shade resin-<br>based dental<br>restorative that can<br>be light-cured by | Tooth shade resin-<br>based dental<br>restorative that can<br>be light-cured by | Same as<br>Predicate<br>Devices. |
| | photo<br>polymerization. | photo<br>polymerization. | photo<br>polymerization. | photo<br>polymerization. | |
| Storage | Store at room<br>temperature 2-28°C<br>(36-82°F). | Store at room<br>temperature 2-28°C<br>(36-82°F). | Store at room<br>temperature 2-<br>27°C. | Store at room<br>temperature 2-27°C. | Similar to<br>Predicate<br>devices. |
| Compatible<br>with<br>methacrylate-<br>based dental<br>adhesives | Yes | Yes | Yes | Yes | Same as<br>Predicate<br>Devices. |
| Recommende<br>d for load-<br>bearing<br>occlusal<br>surfaces | Yes | No | Yes | No | Same as<br>Predicate<br>Devices. |
| Primary<br>Packaging | Syringe and<br>Capsule | Syringe and<br>Capsule | Syringe and<br>Capsule | Syringe and Capsule | Same as<br>Predicate<br>Devices. |
| Material<br>Composition | Methacrylate<br>resins, Photo-<br>initiators,<br>Inorganic fillers | Methacrylate<br>resins, Photo-<br>initiators,<br>Inorganic fillers | Methacrylate<br>resins, Photo-<br>initiators,<br>Inorganic fillers | Methacrylate resins,<br>Photo-initiators,<br>Inorganic fillers | Similar to<br>Predicate<br>devices. |
| Containing<br>Inorganic<br>Fillers | Yes | Yes | Yes | Yes | Same as<br>Predicate<br>Devices. |
| Primary<br>Filler particle<br>size range | 40 nm - 0.4 µm | 40 nm - 0.1 µm | 4 nm - 100 nm | 10 nm - 5.0 µm | Similar to<br>Predicate<br>devices. |
| Curing<br>Mechanism | Photo-initiation | Photo-initiation | Photo-initiation | Photo-initiation | Same as<br>Predicate<br>Devices. |
| Intensity<br>(mW/cm²) for<br>curing | ≥ 650 mW/cm² | ≥ 650 mW/cm² | ≥ 550 mW/cm² | ≥ 550 mW/cm² | Similar to<br>Predicate<br>devices. |
| Wavelength<br>(nm) for<br>curing | 400 - 520 nm | 400 - 520 nm | 400 - 500 nm | 400 - 500 nm | Similar to<br>Predicate<br>Devices. |
| Curing Time<br>(sec) | 20 sec (≥ 650<br>mW/cm²) | 20 sec (≥ 650<br>mW/cm²) | At least 20 sec (≥<br>550 mW/cm²) | 20 sec (≥ 550<br>mW/cm²) | Similar to<br>Predicate<br>Devices. |
| Depth of<br>Cure (mm) | Up to 5mm | Up to 4mm | Up to 5mm | Up to 4mm | Similar to<br>Predicate<br>Devices. |
| Compressive<br>Strength<br>(MPa) | Meet the criteria<br>per internal<br>standard | Meet the criteria<br>per internal<br>standard | Meet the criteria<br>per internal<br>standard | Meet the criteria per<br>internal standard | Similar to<br>Predicate<br>Devices. |
| Internal<br>standard<br>>260 Mpa | | | | | |
| Rockwell<br>Hardness<br>(RHN)<br>Internal<br>Standard<br>>65 RHN | Meet the criteria<br>per internal<br>standard | Meet the criteria<br>per internal<br>standard | Meet the criteria<br>per internal<br>standard | Meet the criteria per<br>internal standard | Similar to<br>Predicate<br>Devices. |
| Flexural<br>Strength<br>(Mpa) | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO 4049<br>requirement | Similar to<br>Predicate<br>Devices. |
| Radio-opacity<br>(mm of AI) | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO 4049<br>requirement | Similar to<br>Predicate<br>Devices. |
| Water<br>Sorption<br>(µg/mm³) | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO 4049<br>requirement | Similar to<br>Predicate<br>Devices. |
| Water<br>Solubility<br>(µg/mm³) | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO 4049<br>requirement | Similar to<br>Predicate<br>Devices. |
| Sensitivity to<br>ambient light | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement | Conform to ISO<br>4049 requirement…
