The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time.
ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm.
The device does not come sterilized and is not intended to be sterilized prior to use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ESTELITE UNIVERSAL FLOW device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from ISO 4049:2009)	Reported Device Performance (ESTELITE UNIVERSAL FLOW)
Sensitivity to ambient light	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Depth of cure	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Flexural strength	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Water sorption	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Solubility	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Shade	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Color stability	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Radiopacity	Conformed to ISO 4049 requirements	Conformed to ISO 4049 requirements
Sterilization	Non-sterile (as per predicate)	Non-sterile
Shelf life	3 years at 0-25°C (32-77°F) (as per predicate)	3 years at 0-25°C (32-77°F)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., how many specimens were tested for flexural strength). It only states that the testing was conducted in accordance with ISO 4049:2009. ISO standards typically specify minimum sample sizes for such tests.

The data provenance is non-clinical testing conducted by the manufacturer, Tokuyama Dental Corporation. The country of origin of the data is not specifically mentioned, but the manufacturer is based in Japan. This testing is prospective for the ESTELITE UNIVERSAL FLOW device, as it was performed to demonstrate conformity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a dental material, and the "ground truth" for its performance characteristics is established by adherence to physical and chemical property standards (ISO 4049:2009), not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "test set" involves physical and chemical property measurements against a standard, not interpretations requiring adjudication.

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 device is a dental restorative material, not an AI-powered diagnostic or assistive technology for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is the requirements specified in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." The device's physical and chemical properties were measured and compared against these established international standards.

For biocompatibility, the ground truth relies on the established safety record of identical ingredients used in previously authorized devices (ESTELITE BULK FILL Flow, ESTELITE SIGMA QUICK, and ESTELITE FLOW QUICK) over many years without reportable adverse incidents. This is justification for not requiring further biocompatibility testing under Section 6 of ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.

Tokuyama Dental Corporation % Keith Barritt Official Correspondent Fish & Richardson P.C. 1000 Maine Ave., S.W., Suite 1000 Washington, District of Columbia 20024

Re: K180613

Trade/Device Name: Estelite Universal Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material. Regulatory Class: Class II Product Code: EBF Dated: May 30, 2018 Received: June 5, 2018

Dear 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

July 12, 2018

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For 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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EXHIBIT 11

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Indications for Use

510(k) Number (if known)

Device Name ESTELITE UNIVERSAL FLOW

Indications for Use (Describe)

The ESTELITE UNIVERSAL FLOW device is indicated for use as a tooth shade resin material in dental procedures, such as:

Direct anterior and posterior restorations
Cavity base or liner
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 UNIVERSAL FLOW tooth shade resin material

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. 901 15th Street, N.W., Suite 700 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com

(ii) Preparation Date

May 30, 2018

Device

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

ESTELITE UNIVERSAL FLOW tooth shade resin material material, tooth shade, resin 2 EBF

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Predicate Device

Primary Predicate: Tokuyama Dental Corporation's ESTELITE BULK FILL Flow (K#161353).

Reference Devices: Tokuyama Dental Corporation's ESTELITE SIGMA QUICK (K#080940), and Tokuyama Dental Corporation's ESTELITE FLOW QUICK (K#051808).

Device Description

ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm.

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

Indications for Use

The ESTELITE UNIVERSAL FLOW device is indicated for use as a tooth shade resin material in dental procedures, such as:

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

Comparison of Technological Characteristics

The ESTELITE UNIVERSAL 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 UNIVERSAL FLOW device does not have its own energy source.

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For purposes of performance characteristics for obtaining FDA marketing authorization, the ESTELITE UNIVERSAL FLOW device is substantially equivalent to Tokuyama's own primary predicate, the ESTELITE BULK FILL Flow (K#161353), as shown below:

			Subject device	Primary predicate	Difference
Device name			ESTELITE UNIVERSAL FLOW	ESTELITE BULK FILL Flow
Manufacturer			Tokuyama Dental	Tokuyama Dental
510(k) No.			(Pending)	K161353
Classification name			Material, Tooth Shade, Resin	Material, Tooth Shade, Resin
Indications for Use			For use as a tooth shade resinmaterial in dental procedures, suchas:- Direct anterior and posteriorrestorations- Cavity base or liner- Blocking out cavity undercuts beforefabricating indirect restorations- Repair of porcelain/composite	For use as a tooth shade resinmaterial in dental procedures, suchas:- Direct anterior and posteriorrestorations- Cavity lining- Blocking out cavity undercuts beforefabricating indirect restorations- Repair of porcelain/composite	The indications for Use of subjectdevice is essentially the same aspredicate device.
Principle of operation			Tooth shade resin material that iscured by photo polymerization.(Light-cure)	Tooth shade resin material that iscured by photo polymerization.(Light-cure)
Material	Filler		· Silica-zirconia filler· Composite filler	· Silica-zirconia filler· Composite filler	The subject device consists mainly offillers and methacrylates as with the
	Resinmatrixmonomer		- Bisphenol A polyethoxymethacrylate (Bis-MPEPP)- Bisphenol A di(2-hydroxypropoxy) dimethacrylate(Bis-GMA)- Triethylene glycoldimethacrylate (TEGDMA)- 1,6-bis(methacryl-ethyloxycarbonylamino)trimethyl hexane(UDMA)	- Bisphenol A polyethoxymethacrylate (Bis-MPEPP)- Bisphenol A di(2-hydroxypropoxy) dimethacrylate(Bis-GMA)- Triethylene glycol dimethacrylate(TEGDMA)	predicate device.Since all of the ingredients to be used inthe subject device have already beenused in such existing devices as EsteliteSigma Quick (K080940), Estelite FlowQuick (K051808) and Estelite Bulk FillFlow (K161353), the safety of subjectdevice is assured.
Physical	property	Sensitivityto ambientlight	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Each device conforms to therequirements of ISO 4049 andtherefore the ESTELITEUNIVERSAL FLOW device issubstantially equivalent.
		Depth ofcure	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Flexuralstrength		Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Watersorption		Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Solubility		Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Shade		Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Colorstability		Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials

Comparison of ESTELITE UNIVERSAL FLOW device with the primary predicate

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	Radio-opacity	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
Sterilization		Non-sterile	Non-sterile
Shelf life		3 years at a temperature between0-25°C (32-77F°)	3 years at a temperature between0-25°C (32-77F°)

Shelf Life Testing

Tokuyama tested each of the three viscosities of the device to establish a shelf life of three years at a temperature between 0-25°C (32-77Fº).

Material And Chemical Composition

For purposes of material and chemical composition, the ESTELITE UNIVERSAL FLOW device has the same basic characteristics as Tokuyama's own ESTELITE BULK FILL Flow (K#161353), ESTELITE SIGMA QUICK (K#080940), and ESTELITE FLOW QUICK (K#051808).

Performance Data Summary

Non-clinical testing of the physical properties of the ESTELITE UNIVERSAL FLOW device was conducted in accordance with ISO 4049:2009, "Dentistry --Polymer-based Restorative Materials." There were no clinical tests performed for the ESTELITE UNIVERSAL FLOW device.

The device does come into direct contact with the patient. The ingredients in the ESTELITE UNIVERSAL FLOW device are the same as in three of Tokuyama's own previously authorized devices, namely ESTELITE BULK FILL Flow (K#161353), ESTELITE SIGMA OUICK (K#080940), and ESTELITE FLOW QUICK (K#051808). 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. Thus, under Section 6 of ISO 10993-1, no further biocompatibility testing is required.

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Comparison of Performance Data of ESTELITE UNIVERSAL FLOW device with the primary predicate

Device name		Subject device	Primary predicate	Difference
510(k) No.		ESTELITE UNIVERSAL FLOW(Pending)	ESTELITE BULK FILL FlowK161353
Physicalproperty	Sensitivityto ambientlight	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Each device conforms to therequirements of ISO 4049 andtherefore the ESTELITEUNIVERSAL FLOW device issubstantially equivalent.
	Depth ofcure	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Flexuralstrength	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Watersorption	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Solubility	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Shade	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Colorstability	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
	Radio-opacity	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials	Conformed to the requirement ofISO 4049 Dentistry -- Polymer-based restorative materials
Sterilization		Non-sterile	Non-sterile
Shelf life		3 years at a temperature between0-25°C (32-77F°)	3 years at a temperature between0-25°C (32-77F°)

Conclusion

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

41334960.doc

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.