ESTELITE BULK FILL Flow is a low viscosity, light cured radiopaque composite dental tooth shade resin material. This low stress flowable material can be placed in 4 mm increments. The device incorporates Radical-Amplified Photopolymerization (RAP) initiator technology, which facilitates a shortened light curing time and ample working time. The device comes in five shades, namely U (Universal), A1, A2, A3, and B1.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Tokuyama Dental Corporation's "ESTELITE BULK FILL Flow tooth shade resin material." The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a table comparing the new device (ESTELITE BULK FILL Flow) to its primary predicate (ESTELITE FLOW QUICK) and references ISO 4049:2009 for many properties.

Characteristic	Acceptance Criteria (Predicate/ISO 4049)	Reported Device Performance (ESTELITE BULK FILL Flow)
Sensitivity to Ambient Light	Material remained physically homogenous (A3)	Material remained physically homogenous (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Depth of Cure (mm)	2.0 ± 0.1 (A3)	4.0 ± 0.1 (Universal); 3.6 ± 0.1 (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Flexural Strength (MPa)	152.5 ± 20.2 (A3)	146 ± 4 (A3)
Water Sorption (µg/mm³)	9.0 ± 0.1 (A3)	22.5 ± 0.5 (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Solubility (µg/mm³)	0.6 ± 0.2 (A3)	0.6 ± 0.3 (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Shade	Matched shade guide (A3)	Matched shade guide (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Color Stability	Slight change in color observed (A3)	No more than a slight change in color observed (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Radio-opacity (mm of Al)	1.2 (A3)	1.7 (A3)
	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Compressive Strength (MPa)	375 ± 26 (A3)	371 ± 10 (A3)
Elastic Modulus (GPa)	8.8 ± 0.4 (A3)	7.5 ± 0.1 (A3)
Surface Hardness (Hy)	44 (A3)	35 (A3)
Diametral Tensile Strength	Conformed to ISO 4049 requirement	Conformed to ISO 4049 requirement
Biocompatibility	All ingredients authorized by FDA for similar devices	All ingredients authorized by FDA for similar devices

Note: The document explicitly states "Conformed to the requirement of ISO 4049" for several physical properties, implying these are the acceptance criteria and the device met them. For other properties, the predicate's performance serves as the benchmark for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the non-clinical physical property tests. It only states that the testing was "conducted in accordance with ISO 4049:2009," which would imply adherence to its specified sample sizes if applicable.

The provenance of the data is implied to be from Tokuyama Dental Corporation, which is based in Japan, as per the submitter information. The testing is non-clinical, so the retrospective/prospective distinction for human data is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the studies conducted were non-clinical, measuring physical properties of the material in a laboratory setting, not evaluating diagnostic performance with human judgment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as there were no human expert judgments or adjudications involved in establishing the ground truth for the physical property tests.

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

No. An MRMC comparative effectiveness study was not done. The device is a dental material, not an AI-assisted diagnostic tool. The document states: "There were no clinical tests performed for the ESTELITE BULK FILL Flow device."

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

Yes, in a sense, a standalone assessment of the material's properties was performed by conducting non-clinical physical property tests. However, this is not a "standalone algorithm" in the context of AI. It refers to the intrinsic performance of the material itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance data of the device was established through laboratory measurements of physical properties according to published standards (ISO 4049:2009). For biocompatibility, the ground truth was based on prior FDA authorization of the device's ingredients in other similar devices and the historical absence of adverse events.

8. The sample size for the training set

This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set. The performance data presented are from testing the physical properties of the final product.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 3, 2017

Tokuyama Dental Corporation % Keith Barritt Official Correspondent Fish & Richardson P.c. 1425 K Street, N.W., Suite 1100 Washington, District of Columbia 20005

Re: K161353

Trade/Device Name: Estelite Bulk Fill Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 2, 2017 Received: March 3, 2017

Dear Mr. Keith Barritt:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161353

Device Name

ESTELITE BULK FILL Flow tooth shade resin

Indications for Use (Describe)

For use as a tooth shade resin material in dental procedures, such as:

Direct anterior and posterior restorations
Cavity lining
Blocking out cavity undercuts before fabricating indirect restorations
Repair of porcelain/composite

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)

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510(k) Summary Tokuyama Dental Corporation ESTELITE BULK FILL Flow tooth shade resin material

The following information is provided pursuant to 21 CFR 807.92.

Submitter

(i) 510(k) Submitter

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261

(ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com

(ii) Preparation Date

October 13, 2016

Device

Trade or Proprietary Name: Common Name: Classification Name: Class: Product Code:

ESTELITE BULK FILL Flow tooth shade resin material material, tooth shade, resin 2 EBF

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Predicate Device

For purposes of performance characteristics for obtaining FDA marketing authorization, the ESTELITE BULK FILL Flow device is substantially equivalent to Tokuyama's own primary predicate ESTELITE FLOW QUICK (K#051808), as shown below:

Device name	ESTELITE BULK FILL Flow	ESTELITE FLOW QUICK
Sensitivity to ambient light	Upon visual inspection, the materialremained physically homogenous (A3)	Upon visual inspection, the materialremained physically homogenous (A3)
Depth of cure(1) (mm)	4.0 ± 0.1 (Universal)3.6 ± 0.1 (A3)	2.0±0.1 (A3)
Flexural strength (MPa)(1)	146 ± 4 (A3)	152.5 ± 20.2 (A3)
Water sorption(1)(µg/mm3)	22.5 ± 0.5 (A3)	9.0 ± 0.1 (A3)
Solubility(1) (µg/mm3)	0.6 ± 0.3 (A3)	0.6 ± 0.2 (A3)
Shade(1)	Upon visual inspection, the shade of the setmaterial matched closely that of a shadeguide (A3)	Upon visual inspection, the shade of the setmaterial matched closely that of a shadeguide (A3)
Color stability(1)	Upon visual inspection, no more than aslight change in color was observed (A3)	Upon visual inspection, no more than aslight change in color was observed (A3)
Radio-opacity(mm of Al)(1)	1.7 (A3)	1.2 (A3)
Compressive strength(1)(MPa)	371 ± 10 (A3)	375 ± 26 (A3)
Elastic modulus(1) (GPa)	7.5 ± 0.1 (A3)	8.8 ± 0.4 (A3)
Surface hardness(1) (Hy)	35 (A3)	44 (A3)

(1) In these evaluation items, the cured material of each device was used as test specimen. The condition to cure each device was as follows:

Device	Intensity for curing	Curing time	Wavelength	Trade name	Manufacturer	) No.	Classification name	Indications for Use	Subject device	Primary predicate	Reference	Nuance FLOW
ESTELITE BULK FILL Flow	800 mW/cm2	10 sec	Using light-curing unit with awavelength of 400-500 nm	ESTELITE BULK FILL Flow	Tokuyama Dental Corporation	(Pending)	Material, Tooth Shade, Resin	For use as a tooth shade resin material in dental procedures, such as:-Direct anterior and posterior restorations.-Cavity lining,-Blocking out cavity undercuts before fabricating indirect restorations-Repair of porcelain/composite materials.	ESTELITE FLOW QUICK	Tokuyama Dental CorporationK051808	Filtek Bulk Fill Flowable Restorative3M ESPE Dental ProductsK120453	Den-Mat Holdings, LLCK143679
ESTELITE FLOW QUICK	800 mW/cm2	10 sec	Using light-curing unit with awavelength of 400-500 nm						Material, Tooth Shade, ResinFor use as a tooth shade resin material in dental procedures	Material, Tooth Shade, ResinBase under Class I and II direct restorations-Liner under direct restorative materials-Pit and fissure sealant-Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)-Class III and V restorations-Undercut blockout-Repair of small enamel defects-Repair of small defects in esthetic indirect restorations-Repair of resin and acrylic temporary materials-As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown	Material, Tooth Shade, ResinNuance FLOW is recommended for the following types of applications:1) Direct restorations of anterior or posterior teeth2) Cavity base/liner3) Intraoral repairs of fracture crowns/bridges	SimilarThe Indications for Use of subject device is within that of the predicate and the reference devices.
				Principle of Operation	Tooth shade resin material that is cured by photo polymerization. (Light-cure)	Tooth shade resin material that is cured by photo polymerization. (Light-cure)	Tooth shade resin material that is cured by photo polymerization. (Light-cure)	Tooth shade resin material that is cured by photo polymerization. (Light-cure)	Similar

Other similar reference devices are ESTELITE FLOW QUICK High Flow (also cleared under K#051808), FILTEK BULK FILL FLOWABLE RESTORATIVE (K#120453), and the nuance FLOW tooth shade resin material (K#143679). As shown above, the K#051808 and K#120453 devices demonstrate that certain characteristics of the subject device that are not included in the ISO 4049:2009 recognized standard but that are included in the FDA's 2005 guidance on Dental Composite Resin Devices are within the norm of similar legally marketed devices. Furthermore, K#120453 is cleared for use as a "liner under direct restorative materials," which is essentially the same as the "cavity liner" indication for Tokuyama's ESTELITE BULK FILL Flow tooth shade resin subject device.

A further chart comparing Tokuyama's ESTELITE BULK FILL Flow tooth shade resin subject device with the ESTELITE FLOW QUICK primary predicate K#051808 and the reference devices K#120453 and K#143679 appears on the following two pages.

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				Similar
Aerial	-Silica-zirconia filler-Composite filler-Bis-GMA-TEGDMA-Bis-MPEPP-Photo-polymerization initiator	-Silica zirconia filler-Silica-titania filler-TEGDMA-Bis-MPEPP-UDMA-Photo-polymerization initiator	-Zirconia/silica filler-Ytterbium trifluoride filler-Bis-GMA-UDMA-Bis-EMA(6)-Procrylat-Photo-polymerization initiator	-Silanated barium glass filler-Silanated colloidal silica-Bis-GMA-Photo-polymerization initiator	The subject device contains a filler, methacrylic monomer and photo-polymerization initiator as with the predicate and the reference devices.Similar
Physical properties
Sensitivity to ambient light	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049
Depth of cure	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049
Diametral tensile strength	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049
Water sorption	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049
Solubility	Conformed to the requirement of ISO 4049			-	Conformed to the requirement of ISO 4049
Shade	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049
Color stability	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049
Radio-opacity	Conformed to the requirement of ISO 4049			Conformed to the requirement of ISO 4049

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For purposes of biocompatibility, the ESTELITE BULK FILL Flow device is substantially equivalent to Tokuyama's own TOKUYAMA BOND FORCE (K#070215), ESTELITE FLOW OUICK (K#051808), and ESTELITE COLOR (K#110178), as all ingredients in the ESTELITE BULK FILL Flow device have been cleared for marketing by the FDA for use in these similar devices.

Device Description

Biocompatibility testing is not required because all the ingredients in the ESTELITE BULK FILL Flow device have already been authorized by the FDA for use in similar devices and Tokuyama Dental Corporation has received almost no complaints of personal adverse effects of any kind (and no serious injury) involving the ingredients used in the ESTELITE BULK FILL Flow device.

The device does not come sterilized and is not intended to be sterilized prior to use.

Indications for Use

The ESTELITE BULK FILL Flow device is indicated for use as a tooth shade resin material in dental procedures, such as:

Direct anterior and posterior restorations
Cavity lining
Blocking out cavity undercuts before fabricating indirect restorations
Repair of porcelain/composite

Comparison of Technological Characteristics

The ESTELITE BULK FILL Flow device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate device identified above, as each device is a tooth shade resin material that is cured by photo polymerization. The ESTELITE BULK FILL Flow device does not have its own energy source.

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For purposes of material and chemical composition, the ESTELITE BULK FILL Flow device has the same basic characteristics as Tokuyama's own Tokuyama's own TOKUYAMA BOND FORCE (K#070215), ESTELITE FLOW QUICK (K#051808), and Estelite Color (K#110178).

Performance Data Summary

Non-clinical testing of the physical properties of the ESTELITE BULK FILL Flow device was conducted in accordance with ISO 4049:2009. There were no clinical tests performed for the ESTELITE BULK FILL Flow device.

The device does come into direct contact with the patient. All of the ingredients in the ESTELITE BULK FILL Flow device have been authorized by the FDA for use in similar Tokuyama devices. Thus, under Section 6 of ISO 10993-1, no further biocompatibility testing is required.

The ingredients in the ESTELITE BULK FILL Flow device are the same as in three of Tokuvama's own previously authorized devices, namely TOKUYAMA BOND FORCE (K#070215), ESTELITE FLOW QUICK (K#051808), and ESTELITE COLOR (K#110178). These devices have been used for many years without any reportable incidents to local health authorities and for which almost no complaints have been received regarding personal adverse effects of any kind and no serious injuries.

Conclusion

Based on the non-clinical testing conducted of the physical properties of the ESTELITE BULK FILL Flow device in comparison to the predicate devices identified above, and on the biocompatibility of authorized devices for the same use with the same ingredients, it is concluded that the ESTELITE BULK FILL Flow device is substantially equivalent to the predicate devices.

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.