(190 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental composite resin, with no mention of AI or ML capabilities.
No.
The device is a restorative material used for aesthetic dental restorations, not a device that treats or prevents a disease or condition.
No
The device is a composite material used for aesthetic dental restorations, not for diagnosing medical conditions. It is a treatment material, not a diagnostic tool.
No
The device description clearly states it is a composite material (resin, organic and inorganic fillers) used for aesthetic restoration, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aesthetic restoration by getting polymerized directly in the oral cavity" for "Direct anterior and posterior restorations." This describes a material used to physically repair or restore a part of the body (teeth), not to diagnose a condition or analyze a sample taken from the body.
- Device Description: The description details a "nano hybrid typed light-curved complex resin" that is applied as a paste and then hardened in the oral cavity. This is consistent with a dental restorative material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on physical properties (depth of cure, flexural strength, water sorption, solubility, color, radio-opacity) and biocompatibility, which are relevant to a restorative material's function and safety within the body. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc. in a diagnostic context).
In summary, the device is a dental restorative material used for physical repair within the oral cavity, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity.
- Direct anterior and posterior restorations
Product codes
EBF
Device Description
The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, anterior, and posterior parts (teeth)
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)
Non-Clinical Performance Data: This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:
-ISO 4049: Dentistry -- Polymer-based restorative materials
-ISO 7405: Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
-ISO 10993-1: Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
-ISO 10993-3: Biological evaluation of medical devices - Part 3: Tests for genotoxicity, Carcinogenicity and reproductive toxicity
-ISO 10993-5: Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity
-ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-ISO 10993-11: Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
Performance tests conducted (Physical properties - ISO 4049:2009):
- Depth of cure (Opaque: 2.8 mm min value; Non opaque: 2.4 mm min value) - Pass
- Sensitivity of ambient light (No change in consistency) - Pass
- Flexural strength (92.6 Mpa min value) - Pass
- Water sorption (5.7 µg/mm³ max value) - Pass
- Solubility (0.7 µg / mm³ max value) - Pass
- Color (matched closely with the manufacturer's shade guide) - Pass
- Color stability (no color change) - Pass
- Radio-opacity (Not less than 3 mm of aluminum) - Pass
Biocompatibility tests conducted:
- Cytotoxicity: ISO 10993-5
- Oral mucosa irritation: ISO 10993-10
- Skin sensitization (LLNA): ISO 10993-10
- Acute Systemic Toxicity: ISO 10993-11
- Genetoxicity: Bacterial Reverse Mutation: ISO 10993-3
- Genetoxicity: Micronucleus test: ISO 10993-3
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
March 20, 2020
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, 28161 Kr
Re: K192510
Trade/Device Name: DIAFIL & DIAFIL Capsule Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: February 14, 2020 Received: February 20, 2020
Dear Kab Lee:
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 medical devices and radiation-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192510
Device Name DIAFIL & DIAFIL Capsule
Indications for Use (Describe)
A composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity.
- Direct anterior and posterior restorations
| 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 |
of conduct of sponsor, and a person is not required to response 1
3
K192510 Diadent Group International
510(k) Summary
1.Application Information
| Date Prepared: | March 20, 2020 |
|---|---|
| Company Name and | |
| Address: | DiaDent Group International |
| 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju- | |
| si, Chungcheongbuk-do, 28161, Republic of Korea | |
| Contact Person: | Kab Sun, Lee |
| Quality Assurance Manager | |
| Phone: +82-43-266-2315 | |
| FAX: +82-43-235-2315 | |
| Email: diadent32@diadent.co.kr |
2.Device Information
| Trade Name | DIAFIL & DIAFIL Capsule |
|---|---|
| Device Type: | Tooth shade resin material |
| Regulation Description: | Material, Tooth Shade, Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3690 |
| Product Code: | EBF |
| Device Class: | II |
3.Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| Primary Predicate Device | |
|---|---|
| 510(k) Number: | K042124 |
| Applicant: | Vericom |
| Device Name: | DenFil |
| Regulation Number: | 21 CFR 872.3690 |
| Product Code: | EBF |
| Device Class: | II |
4.Products configuration
The subject device is packaged with the following:
| Package type | Components |
|---|---|
| Refill Package | 1 Syringe of product (4g) |
| Intro Kit | 1 Syringe of Product (1g) |
| Capsule | 1 Bottle (20capsules) |
4
5.Device Description
The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.
6.Indications for Use
A composite material which has resin organic and inorganic fillers or complex fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations
7.Comparison with Predicate Device
7.1 Comparison Table
This device compares to the legally marketed devices as follows:
| Subject Device | Primary Predicate Device | Image | |||
|---|---|---|---|---|---|
| DIAFIL & DIAFIL Capsule | DENFIL | Composition | - Bis-GMA |
- TEGDMA
- UDMA
- Barium-alumino-silicate
- Silica
- Pigments | - Bis-GMA
- TEGDMA
- UDMA
- Bis-EMA
- Barium-alumino-silicate
- Silica
-Additives |
| | Diadent Group International | Vericom.Co., Ltd | Method of
use | 1) Select the shade
Separate the area to be treated using
rubber dam, etc. Wash the area. Select
the appropriate shade. | 1. Shade selection
Clean teeth with pumice and water to remove
surface stains or extraneous plaque. Teeth
are not monochromatic. Consider shade
and restoration depth. It is desirable to
choose the shade after mocking up.
Alternatively, Vita'Lumin® Vacuum shade
guide may be used. Using of rubber dam is
recommended for isolation. |
| 510(k)
Number | K192510 | K042124 | | 2) Treat the decayed parts
Remove amalgams or bases and
foreign substances at the area to be
treated that can be disturbing during the
treatment | 2. Cavity preparation - Anterior restoration
Using the conventional acid etching, prepare
cavity for all Class III, Class IV, and Class V
restoration. - Posterior restoration
Prepare the cavity. No residual amalgam or
other base material should be left on the
internal surfaces of preparation that would
interfere with light transmission and the
hardening of the restorative material. |
| Description | The product belongs to Group 1, Class 2
of Type 1 according to the standard
classification of ISO 4049. It is a nano
hybrid typed light-curved complex resin
for aesthetic restoration for both anterior
and posterior parts, which is used for
restoration that requires aesthetics
through decay and damage in a form of
paste with unpolymerized dimethacrylate
monomer, inorganic filler, and
photoinitiators mixed. That is, after
recovering with the unpolymerized
product, to make a hard restoration by
polymerizing through dental visible-ray
polymerizer. | DenFil™ is light-cured restorative hybrid
composite resin and accessories for use in
both posterior and anterior restoration.. | | 3) Pulp protection
When the decayed part is deep, the
pulp can be exposed. Therefore,
according to the indicant, cap the pulp
with calcium hydroxide and glass
ionomer. | 3. Pulp Protection
In deep cavities cover the dentin close to the
pulp with a minimum amount of calcium
hydroxide liner leaving the rest of cavity
surface free for bonding. Glass ionomer or
other eugenol-free base materials may be
used, if wished.
- Placement of matrix
Use a matrix system, preferably a transparent
one, with proper
wedging for proximal contracts. Pre-wedging
is advocated to
achieve slight separation and facilitate
optimal proximal contact. |
| Indication for
Use | A composite material which has resin
organic and inorganic fillers or complex
fillers as ingredients, which are being
used for aesthetic restoration by getting
polymerized directly in the oral cavity.
- Direct anterior and posterior
restorations | DenFil™ is indicated for the following
restorative applications;
- Class I, II, V restorations of posterior teeth
- Class III, IV, V restorations of anterior teeth
- Cervical cavities or defects involving root
surfaces | | | |
5
Diadent Group International
6
Diadent Group International
| | 4) Treatment of the enamel and the
dentine
For the pretreatment, according to
the method of use of the products in use,
operate acid etching and application of
adhesive system in order. | 5. Enamel and dentin treatment
Follow the manufacturer's instructions
regarding etching, priming,
adhesive application and curing. It is
recommended to use
DenFil™ Etchant-37 and BC Plus™ or U-
Bond™ |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 5) Application
-Open up the lid, take an adequate
amount of the product out, and fill the
resin at the area to be treated.
Make sure to close the lid after use to
prevent exposure to the light. | 6. Dispensing the composite
- Syringe
Dispense the necessary amount of
restorative material from the
syringe onto the mixing pad by turning the
handle slowly in a
clockwise manner.
A Universal Nano-hybrid Composite
Immediately replace syringe cap. If not used
immediately, the
dispensed material should be protected from
light. Place
restorative material into the cavity using
instrument contained. |
| | (For the capsule type, you can directly
restore the cavity using the dispenser. It
is disposal tip - dispose of it after use.) | - Single dose capsule
Insert capsule into dispenser and rotate to
gain the proper angle
of entrance into cavity. Extrude restorative
directly into cavity,
using a slow and steady pressure.
- Placement
Place and light cure restorative in increments
in 2.5mm levels or
less. For permitting extension of composite
beyond cavity margins,
overfill the cavity slightly. Avoid intense light
in the working field. |
| | 6) Curing
Place a light projector as close as
possible with the surface of the product
filled and project the light for 20 seconds
vertically. (Usage recommendation: D-
Lux)
(Increase the amount of projection when
the projecting strength is below
400mW/cm2. If it is 400mW/cm2 or
higher, reduce the amount of projection.) | 8. Curing
Expose each area of restoration surface to a
visible light source
(400mW/cm²). Hold the light guide tip as close
to the restorative
materials as possible during light exposure.
The recommended
exposure time and maximum increment
thickness for each shade is
shown below. |
| | 7) Finishing up
After restoring with the resin, remove the
remaining resin with a flame-shaped
finishing bur and complete the shape.
Finish up the final grinding using a rubber
polishing point and aluminium oxide
polishing paste. | 9. Finishing
Immediately after curing contour restoration
surfaces with fine
finishing bur or stone. Carefully adjust
occlusion by removing
material with a fine polishing bur or stone. |
| Light curing
time | 20 seconds
(If light curing unit output is below
400mW/cm2, as measured by a
curing radiometer, more time may be
needed.)
A1, A2, A3, A3.5, B1, B2, C1 20sec
A2O, A3O, BL 30sec | 20 seconds
(If light curing unit output is below
400mW/cm2, as measured by a curing
radiometer, more time may be needed.) |
7
Diadent Group International
| Human factor | Ready to use dispending system | Ready to use dispending system |
|---|---|---|
| Shelf life | 3 years | 2 years |
| Period of Use | Long term(> 30 days) | Long term(> 30 days) |
| Biocompatibil | ||
| ity | Biocompatible, conforming to ISO | |
| 10993 | Biocompatible, conforming to ISO | |
| 10993 | ||
| Performance | ||
| Standard | ||
| conformance | Meet ISO 4049 standard | Meet ISO 4049 standard |
7.2 differences
-Indication for Use
| Subject Device | Primary Predicate Device | Discussion |
|---|---|---|
| A composite material which has resin | ||
| organic and inorganic fillers or complex | ||
| fillers as ingredients, which are being | ||
| used for aesthetic restoration by getting | ||
| polymerized directly in the oral cavity. |
- Direct anterior and posterior
restorations | DenFil™ is indicated for the following
restorative applications;
- Class I, II, V restorations of posterior
teeth - Class III, IV, V restorations of
anterior teeth - Cervical cavities or defects involving
root surfaces | Intended use of both
devices include
restorations of restorations
of anterior teeth /
restorations posterior
teeth/ defects involving root
surfaces
Indication for use of both
devices is similar. |
- Material composition
| Subject Device | Predicate Device | Function of ingredient |
|---|---|---|
| DIAFIL | DENFIL | |
| - Bis-GMA |
- TEGDMA
- UDMA | - Bis-GMA
- TEGDMA
- UDMA
- Bis-EMA | Base liquid resin |
| - Barium-alumino-silicate - Silica | - Barium-alumino-silicate
- Silica | Filler |
| Camphorquinone | Camphorquinone | Photoinitiator |
| Pigments | Additives | Colorant |
The raw material compositions of both devices are not identical but the main ingredient is similar and the role and functions are same. Also, the biocompatibility of raw material of subject device is confirmed by Biological safety study. Overall, the raw materials of both devices are similar.
8
Diadent Group International
- Shelf life
The shelf life of the subject device is 3years and the shelf life of the predicate device is 2 years.
8. Non-Clinical Performance Data
This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:
| -ISO 4049 | Dentistry -- Polymer-based restorative materials |
|---|---|
| -ISO 7405 | Dentistry - Evaluation Of Biocompatibility Of Medical |
| Devices Used In Dentistry [Including: Amendment 1 | |
| (2013)] | |
| -ISO 10993-1 | Biological evaluation of medical devices - Part |
| 1:Evaluation and testing within a risk management | |
| process | |
| -ISO 10993-3 | Biological evaluation of medical devices - Part 3: Tests |
| for genotoxicity, Carcinogenicity and reproductive | |
| toxicity | |
| -ISO 10993-5 | Biological evaluation of medical devices - Part 5. Tests |
| for in vitro Cytotoxicity | |
| -ISO 10993-10 | Biological Evaluation Of Medical Devices - Part 10: |
| Tests For Irritation And Skin | |
| Sensitization | |
| -ISO 10993-11 | Biological Evaluation Of Medical Devices - Part 11: |
| Tests For Systemic Toxicity |
The following Performance tests were conducted.
Performance test (Physical properties - ISO 4049:2009):
| Item | Requirement | Result | Pass/Fail |
|---|---|---|---|
| Depth of cure | Opaque: shall be not less than | ||
| 1 mm | Opaque : 2.8 mm (min value) | Pass | |
| Non opaque: shall be not less | |||
| than 1.5 mm | Non opaque :2.4 mm (min value) | ||
| Sensitivity of | |||
| ambient light | Sample shall be no change in | ||
| consistency | There was no change in | ||
| consistency | Pass | ||
| Flexural strength | More than 80 Mpa | 92.6 Mpa (min value) | Pass |
| Water sorption | shall be less than 40 µg/mm³ | 5.7 µg/mm³ (max value) | Pass |
| Solubility | shall be less than 7.5 µg/mm³ | 0.7 µg / mm³ (max value) | Pass |
| Color | Color of samples shall be | ||
| matched closely with the | |||
| manufacturer's shade guide. | Color of samples was matched | ||
| closely with the manufacturer's | |||
| shade guide | Pass | ||
| Color stability | Shall be no color change | There was no color change | Pass |
| Radio-opacity | Sealer shall have radio-opacity | ||
| equivalent to not less than 3 | |||
| mm of aluminum | Not less than 3 mm of aluminum | Pass |
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Diadent Group International
Biocompatibility test:
| Test | Standard (AAMI/ANSI/ISO) |
|---|---|
| Cytotoxicity | • 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests |
| for in vitro Cytotoxicity | |
| Oral mucosa irritation | •10993-10 Biological Evaluation of Medical Devices - Part 10: |
| Tests for irritation and skin sensitization | |
| Skin sensitization | |
| (LLNA) | •10993-10 Biological Evaluation of Medical Devices - Part 10: |
| Tests for irritation and skin sensitization | |
| Acute Systemic Toxicity | • 10993-11 - Biological Evaluation of Medical Devices - Part 11: |
| Tests for Systemic Toxicity | |
| Genetoxicity: Bacterial | |
| Reverse Mutation | • 10993-3 - Biological Evaluation of Medical Devices - Part 3: |
| Tests for genotoxicity, carcinogenicity and reproductive toxicity | |
| Genetoxicity: Micronucleus | |
| test | • 10993-3 - Biological Evaluation of Medical Devices - Part 3: |
| Tests for genotoxicity, carcinogenicity and reproductive toxicity |
9. Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
10. Conclusions
Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.