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.

AI/ML Overview

Please note: The provided document is a 510(k) summary for a dental resin material, not an AI/ML medical device. Therefore, many of the requested elements for describing AI/ML device studies (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this type of traditional medical device submission.

I will address the applicable acceptance criteria and study information as presented in the document for the DENU Composite Resin and DENU Flow Resin.

Here's the information extracted from the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data for two devices: DENU Composite Resin and DENU Flow Resin, comparing them against predicate devices and indicating whether they meet acceptance criteria. The acceptance criteria are implicitly derived from the predicate device values and the referenced ISO standards (ISO 4049 and ISO 10993 series). The document states that "All the test results met the preset test criteria."

DENU Composite Resin

Characteristic	Acceptance Criteria (Predicate range/description)	DENU Composite Resin Performance	Met Acceptance Criteria
Compressive strength	DEB Shade: 370.56 (15.13) MPa; T Shade: 394.01 (25.05) MPa	187.4 (46) MPa	Yes (implied by "Both acceptance criteria")
Flexural strength	DEB Shade: 165.14 (13.59) MPa; T Shade: 157.98 (8.16) MPa	135.74 (11.72) MPa	Yes (implied by "Both acceptance criteria")
Elastic modulus	DEB Shade: 11348 (271) MPa; T Shade: 9180 (431) MPa	7950.5 (464.6) MPa	Yes (implied by "Both acceptance criteria")
Depth of cure	2.60 (0.02) mm	A0: 3.86 (0.15) mm; U0: 3.43 (0.11) mm	Met
Filler particle size distribution	Silica: 20 nm; Zirconia: 4 to 11 nm; cluster filler: 0.6 to 10 microns	Silica: 16 nm; Glass: 4 µm	Met
Surface hardness	78.664 (0.68) KHN	43.86 (3.02) KHN	Met
Radio-opacity	2.1 (0.0) mmAl	3.2 mmAl	Met
Water sorption	33.1 (2.1) µg/mm³	18.48 (0.84) µg/mm³	Met
Solubility	1.0 (0.7) µg/mm³	0.82 (0.76) µg/mm³	Met
Curing time	20 sec (for 2.0mm depth); 40 sec (for 1.5mm depth)	20 sec	Met

DENU Flow Resin

Characteristic	Acceptance Criteria (Predicate range/description)	DENU Flow Resin Performance	Met Acceptance Criteria
Compressive strength	317.82 (17.20) MPa	277.4 (29.4) MPa	Met
Flexural strength	120.96 (18.64) MPa	105.24 (6.74) MPa	Met
Elastic modulus	6815.80 (924.00) MPa	8772.3 (558.1) MPa	Met
Depth of cure	2.837 (0.13) mm	A0: 2.93 (0.05) mm; U0: 2.66 (0.05) mm	Met
Filler particle size distribution	Ytterbium trifluoride: 0.1 to 5.0 µm; Silica: 20 nm, 75 nm; Zirconia/silica cluster: 0.6 to 10 µm	Silica: 16 nm; Glass: 4 µm	Met
Surface hardness	45.124 (0.16) KHN	26.02 (1.83) KHN	Met
Radio-opacity	1.70 (0.05) mmAl	2.7 mmAl	Met
Water sorption	24.87 (2.23) µg/mm³ to 28.32 (1.23) µg/mm³	25.24 (0.88) µg/mm³	Met
Solubility	3.22 (0.20) µg/mm³ to 9.77 (0.69) µg/mm³	1.52 (0.56) µg/mm³	Met
Curing time	20 sec (for 2.0mm depth); 40 sec (for 1.5mm depth)	20 sec	Met

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of specimens) used for each physical property test. It mentions that "The following test articles were tested based on the referenced standard," which refers to ISO 4049 and ISO 10993. These standards typically specify the number of specimens required for each test. The data provenance is laboratory testing of the device itself, not clinical data from a specific country or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a material science study involving physical and chemical property testing, not an AI/ML device relying on expert consensus for ground truth. The "ground truth" is established by direct measurement of the material properties described in the ISO standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts, which is not relevant to laboratory-based material property testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a dental material, not an AI/ML device, so no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a dental material, not an AI/ML algorithm.

7. The type of ground truth used

The ground truth for the performance testing is based on standardized laboratory measurements of physical and biological properties, as defined by the referenced ISO standards (ISO 4049 for physical properties, ISO 10993 for biocompatibility). These are objective, quantitative measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This is a traditional medical device (dental resin), not an AI/ML device that requires a training set. The device formulation and manufacturing process would be optimized through R&D, but not in the context of a "training set" for an algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set as understood in AI/ML, there is no ground truth established for it.

Summary

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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 (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,

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FORM FDA 3881 (6/20)

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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

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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

DescriptiveInformation	New device	Predicate device	Discuss/Justifythe 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
RegulationNumber	21 CFR 872.3690	21 CFR 872.3690	Equivalent
DeviceDescription	DENU Composite Resin islight-cured composite resinwhich can be used in anteriorand posterior teeth. This isclassified into type 1, class 2,group 1 according to 4, ISO in4049:2019.	3MTM ESPETTM FiltekTMUniversal Restorativematerial is a visible-lightactivated, restorativecomposite designed for usein anterior and posteriorrestorations	Equivalent
IntendedUse(includingthe indicationsfor use)	- Direct anterior and posteriorrestorations- Core buildup- Splinting- Indirect anterior andposterior restorationsincluding inlays, onlays andveneers	- Direct anterior andposterior restorations(including occlusalsurfaces)- Core build-ups- Splinting- Indirect restorationsincluding 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
Applicablestandards	ISO 4049ISO 10993	ISO 4049ISO 10993	Equivalent
Physical properties
Compressivestrength	187.4(46) MPa	DEB Shade- 370.56 (15.13) MPaT Shade- 394.01 (25.05) MPa	Bothacceptancecriteria
Flexuralstrength	135.74(11.72) MPa	DEB Shade- 165.14 (13.59) MPaT Shade- 157.98 (8.16) MPa	Bothacceptancecriteria
Elastic modulus	7950.5(464.6) MPa	DEB Shade- 11348 (271) MPaT Shade- 9180 (431) MPa	Bothacceptancecriteria
Depth of cure	A0 - 3.86(0.15) mmUO - 3.43(0.11) mm	2.60(0.02) mm	Bothacceptancecriteria	met
Filler particlesize distribution	Silica filler 16nmGlass filler 4 $ \mu $ m	Silica filler- non-agglomerated/non-aggregated : 20 nmZirconia filler-non-agglomerated/non-aggregated : 4 to11 nmzirconia/silica cluster filler- aggregated : comprised of20 nm silica and 4 to 11 nmzirconia particles	Bothacceptancecriteria	met
Surfacehardness	43.86(3.02) KHN	78.664(0.68) KHN	Bothacceptancecriteria	met
Radio-opacity	3.2 mmAl	2.1(0.0) mmAl	Bothacceptancecriteria	met
Water sorption	18.48(0.84) $\mu$ g/mm3	33.1(2.1) $\mu$ g/mm3	Bothacceptancecriteria	met
Solubility	0.82(0.76) $\mu$ g/mm3	1.0(0.7) $\mu$ g/mm3	Bothacceptancecriteria	met
Curing time	20 sec	Dentin/Enamel/Translucentshade(Increment depth2.0mm) : 20 secDentin, A6B, B5B shade(Increment depth 1.5mm) :	Bothacceptancecriteria	met
		40 sec
Intensityfor curing	400mW/cm²(Halogen or LED)	400 mW/cm2(Halogen or LED)	Equivalent
Wavelength forcuring	400-500 nm (Halogen orLED)	400-500 nm (Halogen orLED)	Equivalent
Sterile	Non-sterile	Non-sterile	Equivalent
Shelf Life	3 years	3 years	Equivalent

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DENU Flow Resin

DescriptiveInformation	New device	Predicate device	Discuss/Justifythe Differences
510(k) Number	New	K100235	-
Trade Name	DENU Flow Resin	FiltekTM Supreme UltraFlowable 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
RegulationNumber	21 CFR 872.3690	21 CFR 872.3690	Equivalent
DeviceDescription	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
IntendedUse(includingthe indicationsfor use)	- Class III restorations- Class V restorations- Small Class I restorations (non stress-bearingrestorations)- 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 ofMaterials	BISGMAUDMATEGDMABa glassSilaneCamphorquinoneEthyl 4-dimethylaminobenzoateTitanium(IV) oxideYellow ferric oxideIron(III) oxideIron(II,III) oxide	BISGMASubstituted DemethacrylateTEGDMASilane treated ceramicSilane Treated SilicaYtterbium Fluoride (Ybf3)Reacted Polycaprolactone PolymerDiphenyliodoniumHexafluorophosphate	Similar
Applicablestandards	ISO 4049ISO 10993	ISO 4049ISO 10993	Equivalent
Compressivestrength	277.4(29.4) MPa	317.82 (17.20) MPa	Bothacceptancecriteria	met
Flexuralstrength	105.24(6.74) MPa	120.96 (18.64) MPa	Bothacceptancecriteria	met
Elastic modulus	8772.3(558.1) MPa	6815.80 (924.00) MPa	Bothacceptancecriteria	met
Depth of cure	A0 - 2.93(0.05) mmUO - 2.66(0.05) mm	2.837(0.13) mm	Bothacceptancecriteria	met
Filler particlesize distribution	Silica filler 16nmglass filler 4 μm	ytterbium trifluoride filler-0.1 to 5.0 micronsSilica filler-non-agglomerated/non-aggregated surfacemodified : 20 nm, 75 nmzirconia/silica cluster filler- surface modifiedaggregated(comprised of20 nm silica and 4 to 11 nmzirconia particles) : 0.6 to10 microns	Bothacceptancecriteria	met
Surfacehardness	26.02(1.83) KHN	45.124(0.16) KHN	Bothacceptancecriteria	met
Radio-opacity	2.7 mmAl	1.70(0.05) mmAl	Bothacceptancecriteria	met
Water sorption	25.24(0.88) µg/mm3	High translucency - 24.87(2.23) µg/mm3Medium translucency -24.48 (1.99) µg/mm3Low translucency - 28.32(1.23) µg/mm3	Bothacceptancecriteria	met
Solubility	1.52(0.56) µg/mm3	High translucency - 3.22(0.20) µg/mm3Medium translucency -6.29 (0.23) µg/mm3Low translucency - 9.77(0.69) µg/mm3	Bothacceptancecriteria	met
Curing time	20 sec	Curing time :Opaque(Increment depth1.5mm) - 40 secAll other shade(Incrementdepth 2.0mm) - 20 sec	Bothacceptancecriteria	met
Intensity forcuring	400mW/cm² (Halogen orLED)	400 mW/cm2 (Halogen orLED)	Equivalent
Wavelength forcuring	400-500 nm (Halogen orLED)	400-500 nm (Halogen orLED)	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.

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.