Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes dental composite resins and their intended uses and performance characteristics. There is no mention of AI or ML technology in the device description, intended use, or performance studies.

Therapeutic

No.
The device is a composite resin for dental restorations and core build-ups, which are structural and aesthetic functions rather than therapeutic.

Diagnostic

No

The provided text describes dental composite resins for restorative procedures, such as fillings and veneers. These materials are used for treatment and repair, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "light-cured composite resin" and "light-cured flowable composite resin," which are physical materials, not software. The performance studies also focus on material properties like strength, solubility, and biocompatibility, further indicating it is a physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended uses are for direct and indirect dental restorations, core buildup, splinting, and pit and fissure sealing. These are all procedures performed directly on the patient's teeth for treatment and restoration.
Device Description: The device is described as a light-cured composite resin used in anterior and posterior teeth. This is a material used in dental procedures.
Anatomical Site: The anatomical site is "anterior and posterior teeth," which are parts of the human body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used to perform tests on samples taken from the body, not to directly treat or restore parts of the body. This device is a dental restorative material used in direct patient care.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use

DENU Composite Resin is indications for use in:

Direct anterior and posterior restorations
Core buildup
Splinting
Indirect anterior and posterior restorations including inlays, onlays and veneers

DENU Flow Resin is indications for use in:

Class III restorations
Class V restorations
Small Class I restorations (non stress-bearing restorations)
Pit and fissure sealing in molars and premolars
Repair of small defects in esthetic indirect inlays
Base/liner under direct restorations

Product codes (comma separated list FDA assigned to the subject device)

EBF, EBC, EJK

Device Description

DENU Composite Resin is light-cured composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2, group 1 according to 4, ISO 4049:2019.

DENU Flow Resin is light-cured flowable composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2 group 1 according to 4, ISO 4049:2019.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior and posterior teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professional

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)

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

ISO 4049 - Sensitivity of ambient light, Depth of cure, Flexural Strength, Water Sorption, Solubility, Radio-opacity, Color/Color Stability
ISO 10993-3 Genotoxicity
ISO 10993-5 - Cytotoxicity
ISO 10993-10 Skin sensitization, Oral mucosa irritation
ISO 10993-11 - Acute systemic toxicity

Key results are summarized in the "Key Metrics" section below.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

DENU Composite Resin

Compressive strength: 187.4(46) MPa
Flexural strength: 135.74(11.72) MPa
Elastic modulus: 7950.5(464.6) MPa
Depth of cure: A0 - 3.86(0.15) mm, UO - 3.43(0.11) mm
Filler particle size distribution: Silica filler 16nm, Glass filler 4 µm
Surface hardness: 43.86(3.02) KHN
Radio-opacity: 3.2 mmAl
Water sorption: 18.48(0.84) µg/mm3
Solubility: 0.82(0.76) µg/mm3
Curing time: 20 sec
Intensity for curing: 400mW/cm² (Halogen or LED)
Wavelength for curing: 400-500 nm (Halogen or LED)
Sterile: Non-sterile
Shelf Life: 3 years

DENU Flow Resin

Compressive strength: 277.4(29.4) MPa
Flexural strength: 105.24(6.74) MPa
Elastic modulus: 8772.3(558.1) MPa
Depth of cure: A0 - 2.93(0.05) mm, UO - 2.66(0.05) mm
Filler particle size distribution: Silica filler 16nm, glass filler 4 µm
Surface hardness: 26.02(1.83) KHN
Radio-opacity: 2.7 mmAl
Water sorption: 25.24(0.88) µg/mm3
Solubility: 1.52(0.56) µg/mm3
Curing time: 20 sec
Intensity for curing: 400mW/cm² (Halogen or LED)
Wavelength for curing: 400-500 nm (Halogen or LED)
Sterile: Non-sterile

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.

K083610, K100235

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 23, 2022

HDI, Inc. Taekyou Kim CEO A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13209 SOUTH KOREA

Re: K213339

Trade/Device Name: DENU Composite Resin, DENU Flow Resin Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: July 22, 2022 Received: July 26, 2022

Dear Taekyou Kim:

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

1

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 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 (OS) 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,

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

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4. INDICATION FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K213339

Device Name DENU Composite Resin, DENU Flow Resin

Indications for Use (Describe) DENU Composite Resin is indications for use in: - Direct anterior and posterior restorations

Core buildup
Splinting
Indirect anterior and posterior restorations including inlays, onlays and veneers

DENU Flow Resin is indications for use in:

Class III restorations
Class V restorations
Small Class I restorations (non stress-bearing restorations)
Pit and fissure sealing in molars and premolars
Repair of small defects in esthetic indirect inlays
Base/liner under direct 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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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

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FORM FDA 3881 (6/20)

Page 1 of 1

POC Publiching Servism (101)-649-4743 EF

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5. 510(k) SUMMARY

K213339

510(k) Summary

Date: July 22, 2022

1. SUBMITTER

HDI, Inc.

A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea TEL : +82-31-735-3510 FAX : +82-31-735-3511 Contact Name: Taekyou Kim Email: hdikorea@hanmail.net

2. DEVICE

· Trade Name: DENU Composite Resin, DENU Flow Resin

·Common Name: Tooth shade resin material

· Classification Name: Material, Tooth shade, Resin

· Regulation Number 872.3690

·Class: 2

·Classification Product Code:

DENU Composite Resin

Primary product code: EBF

DENU Flow Resin

Primary product code: EBF

Secondary product codes: EBC, EJK

3. CLEARED DEVICE (PREDICATE DEVICE)

K083610, FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE, 3M ESPE K100235, FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE, 3M ESPE

4. DEVICE DESCRIPTION

4

DENU Composite Resin is light-cured composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2, group 1 according to 4, ISO 4049:2019.

DENU Flow Resin is light-cured flowable composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2 group 1 according to 4, ISO 4049:2019.

5. INDICATIONS FOR USE

DENU Composite Resin is indicated for use in:

Direct anterior and posterior restorations
Core buildup
Splinting
Indirect anterior and posterior restorations including inlays, onlays and veneers

DENU Flow Resin is indicated for use in:

Class III restorations
Class V restorations
Small Class I restorations (non stress-bearing restorations)
Pit and fissure sealing in molars and premolars
Repair of small defects in esthetic indirect inlays
Base/liner under direct restorations

6. PERFORMANCE TESTING (NON-CLINICAL)

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

. ISO 4049 - Sensitivity of ambient light, Depth of cure, Flexural Strength, Water Sorption, Solubility, Radio-opacity, Color/Color Stability
ISO 10993-3 Genotoxicity
. ISO 10993-5 - Cytotoxicity
ISO 10993-10 Skin sensitization, Oral mucosa irritation •
ISO 10993-11 - Acute systemic toxicity

7. SUBSTANITAL EQUIVALENCE

5

DENU Composite Resin

| Descriptive
Information | New device | Predicate device | Discuss/Justify
the Differences | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----|
| 510(k) Number | New | K083610 | - | |
| Trade Name | DENU Composite Resin | FiltekTM Supreme Ultra Universal Restorative | - | |
| Manufacturer | HDI, Inc. | 3M ESPE | - | |
| Common Name | Tooth shade resin material | Tooth shade resin material | Equivalent | |
| Device Class | 2 | 2 | Equivalent | |
| Product Code | EBF | EBF | Equivalent | |
| Regulation
Number | 21 CFR 872.3690 | 21 CFR 872.3690 | Equivalent | |
| Device
Description | DENU Composite Resin is
light-cured composite resin
which can be used in anterior
and posterior teeth. This is
classified into type 1, class 2,
group 1 according to 4, ISO in
4049:2019. | 3MTM ESPETTM FiltekTM
Universal Restorative
material is a visible-light
activated, restorative
composite designed for use
in anterior and posterior
restorations | Equivalent | |
| Intended
Use(including
the indications
for use) | - Direct anterior and posterior
restorations

Core buildup
Splinting
Indirect anterior and
posterior restorations
including inlays, onlays and
veneers | - Direct anterior and
posterior restorations
(including occlusal
surfaces)
Core build-ups
Splinting
Indirect restorations
including inlays, onlays and | Equivalent | |
| | | veneers | | |
| Intended user | Dental professional | Dental professional | Equivalent | |
| Composition of Materials | BISGMA | BISGMA | Similar | |
| | UDMA | UDMA | | |
| | TEGDMA | TEGDMA | | |
| | Ba glass | BISEMA-6 | | |
| | Silane | PEGDMA | | |
| | Camphorquinone | Silane treated ceramic | | |
| | Ethyl 4-
dimethylaminobenzoate | Silane Treated Silica | | |
| | Titanium(IV) oxide | Silane Treated Zirconia | | |
| | Yellow ferric oxide | Phenyl bis(2,4,6-
trimethylbenzoyl)-
phosphine oxide | | |
| | Iron(III) oxide | | | |
| | Iron(II,III) oxide | | | |
| Applicable
standards | ISO 4049
ISO 10993 | ISO 4049
ISO 10993 | Equivalent | |
| Physical properties | | | | |
| Compressive
strength | 187.4(46) MPa | DEB Shade
370.56 (15.13) MPa
T Shade
394.01 (25.05) MPa | Both
acceptance
criteria | |
| Flexural
strength | 135.74(11.72) MPa | DEB Shade
165.14 (13.59) MPa
T Shade
157.98 (8.16) MPa | Both
acceptance
criteria | |
| Elastic modulus | 7950.5(464.6) MPa | DEB Shade
11348 (271) MPa
T Shade
9180 (431) MPa | Both
acceptance
criteria | |
| Depth of cure | A0 - 3.86(0.15) mm
UO - 3.43(0.11) mm | 2.60(0.02) mm | Both
acceptance
criteria | met |
| Filler particle
size distribution | Silica filler 16nm
Glass filler 4 $ \mu $ m | Silica filler
non-agglomerated/non-
aggregated : 20 nm
Zirconia filler
-non-agglomerated/non-
aggregated : 4 to11 nm
zirconia/silica cluster filler
aggregated : comprised of
20 nm silica and 4 to 11 nm
zirconia particles | Both
acceptance
criteria | met |
| Surface
hardness | 43.86(3.02) KHN | 78.664(0.68) KHN | Both
acceptance
criteria | met |
| Radio-opacity | 3.2 mmAl | 2.1(0.0) mmAl | Both
acceptance
criteria | met |
| Water sorption | 18.48(0.84) $\mu$ g/mm3 | 33.1(2.1) $\mu$ g/mm3 | Both
acceptance
criteria | met |
| Solubility | 0.82(0.76) $\mu$ g/mm3 | 1.0(0.7) $\mu$ g/mm3 | Both
acceptance
criteria | met |
| Curing time | 20 sec | Dentin/Enamel/Translucent
shade(Increment depth
2.0mm) : 20 sec
Dentin, A6B, B5B shade
(Increment depth 1.5mm) : | Both
acceptance
criteria | met |
| | | 40 sec | | |
| Intensity
for curing | 400mW/cm²
(Halogen or LED) | 400 mW/cm2
(Halogen or LED) | Equivalent | |
| Wavelength for
curing | 400-500 nm (Halogen or
LED) | 400-500 nm (Halogen or
LED) | Equivalent | |
| Sterile | Non-sterile | Non-sterile | Equivalent | |
| Shelf Life | 3 years | 3 years | Equivalent | |

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8

DENU Flow Resin

| Descriptive
Information | New device | Predicate device | Discuss/Justify
the Differences | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----|
| 510(k) Number | New | K100235 | - | |
| Trade Name | DENU Flow Resin | FiltekTM Supreme Ultra
Flowable Restorative | - | |
| Manufacturer | HDI, Inc. | 3M ESPE | - | |
| Common Name | Tooth shade resin material | Tooth shade resin material | Equivalent | |
| Device Class | 2 | 2 | Equivalent | |
| Product Code | EBF | EBF | Equivalent | |
| Regulation
Number | 21 CFR 872.3690 | 21 CFR 872.3690 | Equivalent | |
| Device
Description | DENU Flow Resin is light-cured flowable composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2 group 1 according to 4, ISO 4049:2019. | Filtek Supreme Ultra Flowable Restorative, is a low viscosity, visible-light activated, flowable nanocomposite. | Equivalent | |
| Intended
Use(including
the indications
for use) | - Class III restorations

Class V restorations
Small Class I restorations (non stress-bearing
restorations)
Pit and fissure sealing in molars and premolars
Repair of small defects in esthetic indirect inlays
Base/liner under direct restorations | -Class III and V restorations
Restoration of minimally invasive cavity preparations (including small, non stress-bearing occiusal restorations)
Base/liner under direct restorations
Repair of small defects in esthetic indirect restorations
Pit and fissure sealant
Undercut blockout
Repair of resin and acrylic temporary materials | Equivalent | |
| Intended user | Dental professional | Dental professional | Equivalent | |
| Composition of
Materials | BISGMA
UDMA
TEGDMA
Ba glass
Silane
Camphorquinone
Ethyl 4-dimethylaminobenzoate
Titanium(IV) oxide
Yellow ferric oxide
Iron(III) oxide
Iron(II,III) oxide | BISGMA
Substituted Demethacrylate
TEGDMA
Silane treated ceramic
Silane Treated Silica
Ytterbium Fluoride (Ybf3)
Reacted Polycaprolactone Polymer
Diphenyliodonium
Hexafluorophosphate | Similar | |
| Applicable
standards | ISO 4049
ISO 10993 | ISO 4049
ISO 10993 | Equivalent | |
| Compressive
strength | 277.4(29.4) MPa | 317.82 (17.20) MPa | Both
acceptance
criteria | met |
| Flexural
strength | 105.24(6.74) MPa | 120.96 (18.64) MPa | Both
acceptance
criteria | met |
| Elastic modulus | 8772.3(558.1) MPa | 6815.80 (924.00) MPa | Both
acceptance
criteria | met |
| Depth of cure | A0 - 2.93(0.05) mm
UO - 2.66(0.05) mm | 2.837(0.13) mm | Both
acceptance
criteria | met |
| Filler particle
size distribution | Silica filler 16nm
glass filler 4 μm | ytterbium trifluoride filler
-0.1 to 5.0 microns
Silica filler
-non-agglomerated/non-
aggregated surface
modified : 20 nm, 75 nm
zirconia/silica cluster filler
surface modified
aggregated(comprised of
20 nm silica and 4 to 11 nm
zirconia particles) : 0.6 to
10 microns | Both
acceptance
criteria | met |
| Surface
hardness | 26.02(1.83) KHN | 45.124(0.16) KHN | Both
acceptance
criteria | met |
| Radio-opacity | 2.7 mmAl | 1.70(0.05) mmAl | Both
acceptance
criteria | met |
| Water sorption | 25.24(0.88) µg/mm3 | High translucency - 24.87
(2.23) µg/mm3
Medium translucency -
24.48 (1.99) µg/mm3
Low translucency - 28.32
(1.23) µg/mm3 | Both
acceptance
criteria | met |
| Solubility | 1.52(0.56) µg/mm3 | High translucency - 3.22
(0.20) µg/mm3
Medium translucency -
6.29 (0.23) µg/mm3
Low translucency - 9.77
(0.69) µg/mm3 | Both
acceptance
criteria | met |
| Curing time | 20 sec | Curing time :
Opaque(Increment depth
1.5mm) - 40 sec
All other shade(Increment
depth 2.0mm) - 20 sec | Both
acceptance
criteria | met |
| Intensity for
curing | 400mW/cm² (Halogen or
LED) | 400 mW/cm2 (Halogen or
LED) | Equivalent | |
| Wavelength for
curing | 400-500 nm (Halogen or
LED) | 400-500 nm (Halogen or
LED) | Equivalent | |
| Sterile | Non-sterile | Non-sterile | Equivalent | |

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8. SUBSTANTIAL EQUIVALENCE DISCUSSION

DENU Composite Resin/DENU Flow Resin have the same Indications for Use and the principle of operations as the predicate devices. They are intended to perform as lightcured resin which met the requirement according to ISO 4049. They demonstrate similar physical properties and biocompatibilities with comparable performance specifications to the predicate devices.

12

The chemical compositions might be slightly different from the predicate devices, however subject devices and predicate devices use same resin matrix based on BISGMA, UDMA and TEGDMA. Other compositions such as filler, photoinitiator, and pigment operate under the same principle of operations.

The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that DENU Composite Resin/DENU Flow Resin is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable.

9. CONCLUSION

HDI Inc. believes that DENU Composite Resin and DENU Flow Resin are substantially equivalent to the legally marketed predicate device. They do not introduce new indications for use, has similar technological characteristics and do not introduce any new safety or effectiveness concerns.