DENU Composite Resin, DENU Flow Resin

K213339 · Hdi, Inc. · EBF · Sep 23, 2022 · Dental

Device Facts

• Record ID: K213339
• Device Name: DENU Composite Resin, DENU Flow Resin
• Applicant: Hdi, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 23, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

DENU Composite Resin and DENU Flow Resin are light-cured tooth shade resin materials used by dental professionals for restorative dentistry. The devices are applied to tooth structures and cured using a dental light source (400-500 nm, 400 mW/cm²) to harden the material. DENU Composite Resin is used for direct/indirect restorations, core buildup, and splinting; DENU Flow Resin is a lower-viscosity version used for Class I/III/V restorations, pit and fissure sealing, and as a base/liner. The materials function by filling and restoring tooth defects, providing structural support and esthetic correction. Clinical benefit is achieved through the restoration of tooth form and function.

Clinical Evidence

Bench testing only. Testing included ISO 4049 (depth of cure, flexural strength, water sorption, solubility, radio-opacity, color stability) and ISO 10993 (genotoxicity, cytotoxicity, skin sensitization, oral mucosa irritation, acute systemic toxicity). All results met preset acceptance criteria.

Technological Characteristics

Light-cured resin materials (BISGMA, UDMA, TEGDMA matrix). Fillers: Ba glass, silica. Photoinitiators: Camphorquinone, Ethyl 4-dimethylaminobenzoate. Pigments: Titanium(IV) oxide, iron oxides. Non-sterile. Curing: 400-500 nm wavelength, 400 mW/cm² intensity. Compliant with ISO 4049 (Type 1, Class 2, Group 1) and ISO 10993.

Indications for Use

Indicated for dental professionals performing direct/indirect anterior and posterior restorations, core buildup, splinting, Class I/III/V restorations, pit and fissure sealing, and base/liner applications.

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

• FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE (K083610)
• FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE (K100235)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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.

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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 : [phone] FAX : [phone] Contact Name: Taekyou Kim Email: [e-mail]

### 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

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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

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# DENU Composite Resin

| Descriptive<br>Information | New device | Predicate device | Discuss/Justify<br>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<br>Number | 21 CFR 872.3690 | 21 CFR 872.3690 | Equivalent | |
| Device<br>Description | DENU Composite Resin is<br>light-cured composite resin<br>which can be used in anterior<br>and posterior teeth. This is<br>classified into type 1, class 2,<br>group 1 according to 4, ISO in<br>4049:2019. | 3MTM ESPETTM FiltekTM<br>Universal Restorative<br>material is a visible-light<br>activated, restorative<br>composite designed for use<br>in anterior and posterior<br>restorations | Equivalent | |
| Intended<br>Use(including<br>the indications<br>for use) | - Direct anterior and posterior<br>restorations<br>- Core buildup<br>- Splinting<br>- Indirect anterior and<br>posterior restorations<br>including inlays, onlays and<br>veneers | - Direct anterior and<br>posterior restorations<br>(including occlusal<br>surfaces)<br>- Core build-ups<br>- Splinting<br>- Indirect restorations<br>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-<br>dimethylaminobenzoate | Silane Treated Silica | | |
| | Titanium(IV) oxide | Silane Treated Zirconia | | |
| | Yellow ferric oxide | Phenyl bis(2,4,6-<br>trimethylbenzoyl)-<br>phosphine oxide | | |
| | Iron(III) oxide | | | |
| | Iron(II,III) oxide | | | |
| Applicable<br>standards | ISO 4049<br>ISO 10993 | ISO 4049<br>ISO 10993 | Equivalent | |
| Physical properties | | | | |
| Compressive<br>strength | 187.4(46) MPa | DEB Shade<br>- 370.56 (15.13) MPa<br>T Shade<br>- 394.01 (25.05) MPa | Both<br>acceptance<br>criteria | |
| Flexural<br>strength | 135.74(11.72) MPa | DEB Shade<br>- 165.14 (13.59) MPa<br>T Shade<br>- 157.98 (8.16) MPa | Both<br>acceptance<br>criteria | |
| Elastic modulus | 7950.5(464.6) MPa | DEB Shade<br>- 11348 (271) MPa<br>T Shade<br>- 9180 (431) MPa | Both<br>acceptance<br>criteria | |
| Depth of cure | A0 - 3.86(0.15) mm<br>UO - 3.43(0.11) mm | 2.60(0.02) mm | Both<br>acceptance<br>criteria | met |
| Filler particle<br>size distribution | Silica filler 16nm<br>Glass filler 4 $ \mu $ m | Silica filler<br>- non-agglomerated/non-<br>aggregated : 20 nm<br>Zirconia filler<br>-non-agglomerated/non-<br>aggregated : 4 to11 nm<br>zirconia/silica cluster filler<br>- aggregated : comprised of<br>20 nm silica and 4 to 11 nm<br>zirconia particles | Both<br>acceptance<br>criteria | met |
| Surface<br>hardness | 43.86(3.02) KHN | 78.664(0.68) KHN | Both<br>acceptance<br>criteria | met |
| Radio-opacity | 3.2 mmAl | 2.1(0.0) mmAl | Both<br>acceptance<br>criteria | met |
| Water sorption | 18.48(0.84) $\mu$ g/mm3 | 33.1(2.1) $\mu$ g/mm3 | Both<br>acceptance<br>criteria | met |
| Solubility | 0.82(0.76) $\mu$ g/mm3 | 1.0(0.7) $\mu$ g/mm3 | Both<br>acceptance<br>criteria | met |
| Curing time | 20 sec | Dentin/Enamel/Translucent<br>shade(Increment depth<br>2.0mm) : 20 sec<br>Dentin, A6B, B5B shade<br>(Increment depth 1.5mm) : | Both<br>acceptance<br>criteria | met |
| | | 40 sec | | |
| Intensity<br>for curing | 400mW/cm²<br>(Halogen or LED) | 400 mW/cm2<br>(Halogen or LED) | Equivalent | |
| Wavelength for<br>curing | 400-500 nm (Halogen or<br>LED) | 400-500 nm (Halogen or<br>LED) | Equivalent | |
| Sterile | Non-sterile | Non-sterile | Equivalent | |
| Shelf Life | 3 years | 3 years | Equivalent | |

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## DENU Flow Resin

| Descriptive<br>Information | New device | Predicate device | Discuss/Justify<br>the Differences | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----|
| 510(k) Number | New | K100235 | - | |
| Trade Name | DENU Flow Resin | FiltekTM Supreme Ultra<br>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<br>Number | 21 CFR 872.3690 | 21 CFR 872.3690 | Equivalent | |
| Device<br>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<br>Use(including<br>the indications<br>for use) | - Class III restorations<br>- Class V restorations<br>- Small Class I restorations (non stress-bearing<br>restorations)<br>- Pit and fissure sealing in molars and premolars<br>- Repair of small defects in esthetic indirect inlays<br>- Base/liner under direct restorations | -Class III and V restorations<br>- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occiusal restorations)<br>- Base/liner under direct restorations<br>- Repair of small defects in esthetic indirect restorations<br>- Pit and fissure sealant<br>- Undercut blockout<br>- Repair of resin and acrylic temporary materials | Equivalent | |
| Intended user | Dental professional | Dental professional | Equivalent | |
| Composition of<br>Materials | BISGMA<br>UDMA<br>TEGDMA<br>Ba glass<br>Silane<br>Camphorquinone<br>Ethyl 4-dimethylaminobenzoate<br>Titanium(IV) oxide<br>Yellow ferric oxide<br>Iron(III) oxide<br>Iron(II,III) oxide | BISGMA<br>Substituted Demethacrylate<br>TEGDMA<br>Silane treated ceramic<br>Silane Treated Silica<br>Ytterbium Fluoride (Ybf3)<br>Reacted Polycaprolactone Polymer<br>Diphenyliodonium<br>Hexafluorophosphate | Similar | |
| Applicable<br>standards | ISO 4049<br>ISO 10993 | ISO 4049<br>ISO 10993 | Equivalent | |
| Compressive<br>strength | 277.4(29.4) MPa | 317.82 (17.20) MPa | Both<br>acceptance<br>criteria | met |
| Flexural<br>strength | 105.24(6.74) MPa | 120.96 (18.64) MPa | Both<br>acceptance<br>criteria | met |
| Elastic modulus | 8772.3(558.1) MPa | 6815.80 (924.00) MPa | Both<br>acceptance<br>criteria | met |
| Depth of cure | A0 - 2.93(0.05) mm<br>UO - 2.66(0.05) mm | 2.837(0.13) mm | Both<br>acceptance<br>criteria | met |
| Filler particle<br>size distribution | Silica filler 16nm<br>glass filler 4 μm | ytterbium trifluoride filler<br>-0.1 to 5.0 microns<br>Silica filler<br>-non-agglomerated/non-<br>aggregated surface<br>modified : 20 nm, 75 nm<br>zirconia/silica cluster filler<br>- surface modified<br>aggregated(comprised of<br>20 nm silica and 4 to 11 nm<br>zirconia particles) : 0.6 to<br>10 microns | Both<br>acceptance<br>criteria | met |
| Surface<br>hardness | 26.02(1.83) KHN | 45.124(0.16) KHN | Both<br>acceptance<br>criteria | met |
| Radio-opacity | 2.7 mmAl | 1.70(0.05) mmAl | Both<br>acceptance<br>criteria | met |
| Water sorption | 25.24(0.88) µg/mm3 | High translucency - 24.87<br>(2.23) µg/mm3<br>Medium translucency -<br>24.48 (1.99) µg/mm3<br>Low translucency - 28.32<br>(1.23) µg/mm3 | Both<br>acceptance<br>criteria | met |
| Solubility | 1.52(0.56) µg/mm3 | High translucency - 3.22<br>(0.20) µg/mm3<br>Medium translucency -<br>6.29 (0.23) µg/mm3<br>Low translucency - 9.77<br>(0.69) µg/mm3 | Both<br>acceptance<br>criteria | met |
| Curing time | 20 sec | Curing time :<br>Opaque(Increment depth<br>1.5mm) - 40 sec<br>All other shade(Increment<br>depth 2.0mm) - 20 sec | Both<br>acceptance<br>criteria | met |
| Intensity for<br>curing | 400mW/cm² (Halogen or<br>LED) | 400 mW/cm2 (Halogen or<br>LED) | Equivalent | |
| Wavelength for<br>curing | 400-500 nm (Halogen or<br>LED) | 400-500 nm (Halogen or<br>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.

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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.