The OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments.
The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.
OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.

AI/ML Overview

The provided document outlines the substantial equivalence of OMNICHROMA FLOW BULK, a tooth shade resin material, to existing predicate devices. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide details on acceptance criteria or study elements related to AI performance, multi-reader multi-case studies, or ground truth establishment in the context of an AI device.

The document focuses on the physical and chemical properties of the dental resin and its compliance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials."

Here's an analysis of the provided text in relation to your request, highlighting where information is absent for an AI device:

Acceptance Criteria and Device Performance (for a physical dental material):

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

The acceptance criteria for the OMNICHROMA FLOW BULK device are its conformity to the requirements of ISO 4049:2009. The reported device performance for all tested physical properties (Sensitivity to ambient light, Depth of cure, Flexural strength, Water sorption, Solubility, Color stability, Radio-opacity) is that it "Conformed to the requirement of ISO 4049".

Physical Property	Acceptance Criteria (Based on ISO 4049:2009)	Reported Device Performance (OMNICHROMA FLOW BULK)
Sensitivity to ambient light	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Depth of cure	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Flexural strength	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Water sorption	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Solubility	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Color stability	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Radio-opacity	Conforms to ISO 4049:2009 requirements	Conformed to the requirement of ISO 4049
Sterilization	Non-sterile	Non-sterile
Shelf life	3 years at 0-25°C (32-77F°)	3 years at a temperature between 0-25°C (32-77F°)

Since this document describes a dental material and not an AI model, the following points of your request are not applicable or information is not present in the provided text.

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 states "Non-clinical testing of the physical properties of the OMNICHROMA FLOW BULK device was conducted in accordance with ISO 4049:2009". It does not specify the sample size (e.g., number of material samples tested) for each physical property.
Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned as this is materials testing, not patient data.

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):

Not applicable. Ground truth in this context refers to the defined physical and chemical properties as measured in a lab according to ISO standards, not expert consensus on medical images.

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

Not applicable. No expert adjudication is described for 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 not an AI device.

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

Not applicable. This is not an AI algorithm.

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

For material properties, the "ground truth" is established by highly controlled laboratory measurements and adherence to the specifications outlined in the international standard ISO 4049:2009.

8. The sample size for the training set:

Not applicable/not specified. The device is a physical material, not an AI model requiring a training set.

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

Not applicable. There is no training set mentioned or implied for this submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 3, 2021

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

Re: K203598

Trade/Device Name: Omnichroma Flow Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 8, 2020 Received: December 9, 2020

Dear Keith Baritt:

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

{1}------------------------------------------------

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) 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 (QS) 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 medical devices and radiation-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,

For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203598

Device Name

OMNICHROMA FLOW BULK

Indications for Use (Describe)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K203598

510(k) Summary Tokuyama Dental Corporation OMNICHROMA FLOW BULK 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. 1000 Maine Avenue, S.W. Suite 1000 Washington, DC 20024 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com

(iii) Preparation Date

February 2, 2021

Device

Trade or Proprietary Name:	OMNICHROMA FLOW BULK
Common Name:	tooth shade resin material
Classification Name:	material, tooth shade, resin
Class:	2
Product Code:	EBF

{4}------------------------------------------------

Predicate Device

Primary Predicates: Tokuyama Dental Corp.'s ESTELITE BULK FILL Flow (K#161353) andOMNICHROMA FLOW (K#193537)
Reference Devices for Performance:Tokuyama Dental Corp.'s ESTELITE UNIVERSAL FLOW High(K#180613)
Additional Reference Devices for Biocompatibility:Tokuyama Dental Corp.'s OMNICHROMA (K#173275) andESTELITE FLOW QUICK High Flow (K#051808)

Device Description

The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.

OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.

The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.

Indications for Use

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 OMNICHROMA FLOW BULK 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 OMNICHROMA FLOW BULK device does not have its own energy source.

{5}------------------------------------------------

For purposes of performance characteristics for obtaining FDA marketing authorization, the OMNICHROMA FLOW BULK device is substantially equivalent to Tokuyama's own predicate devices, the ESTELITE BULK FILL Flow device (K#161353) and the OMNICHROMA FLOW (K#193537), as shown below:

		Subject device	Predicate #1	Predicate #2	Difference
Device name		OMNICHROMA FLOWBULK	ESTELITE BULK FILLFlow	OMNICHROMAFLOW	-
Manufacturer		Tokuyama Dental	Tokuyama Dental	Tokuyama Dental	-
510(k) No.		K203598	K161353	K193537	-
Health Canada licence No.		(Pending)	98095	104170	-
Classification name		Material, Tooth Shade,Resin	Material, Tooth Shade,Resin	Material, Tooth Shade,Resin	-
Indications for Use		For use as a tooth shaderesin material in dentalprocedures such as:- Direct anterior andposterior restorations- Cavity base or liner- Blocking out cavityundercuts beforefabricating indirectrestorations- Repair ofporcelain/composite	For use as a tooth shaderesin material in dentalprocedures such as:- Direct anterior andposterior restorations- Cavity lining- Blocking out cavityundercuts beforefabricating indirectrestorations- Repair ofporcelain/composite	- Direct anterior andposteriorrestorations- Cavity base or liner- Repair ofporcelain/composite	SimilarThe indicationsfor Use of subjectdevice is withinthat of thepredicate andreference devices.
Component	Container	Syringe	Syringe or Pre-loaded tip	Syringe	SimilarThe containertype of subjectdevice is withinthat of thepredicate andreference devices.
	Shade	1 shade	4 shades	1 shade	SimilarThe number ofshade of subjectdevice is withinthat of thepredicate andreference devices.
Principle of operation		Tooth shade resin materialthat is cured by photopolymerization. (Light-cure)	Tooth shade resinmaterial that is cured byphoto polymerization.(Light-cure)	Tooth shade resinmaterial that is curedby photopolymerization.(Light-cure)	Identical
Material	Filler	- Silica-zirconia filler-Composite filler	- Silica-zirconia filler- Composite filler	- Silica-zirconia filler- Composite filler	SimilarThe subjectdevice consistsmainly of fillersand methacrylatesas with thepredicate andreference devices.Thebiocompatibilityof the device hasbeen thoroughlyevaluated andperformancetested.
	Resin matrixmonomer	-1,6-bis(methacryl-ethyloxycarbonylamino)trimethylhexane (UDMA)-Triethylene glycoldimethacrylate(TEGDMA)	- Bisphenol A di(2-hydroxypropoxy)dimethacrylate (Bis-GMA)- Bisphenol Apolyethoxymethacrylate (Bis-MPEPP)- Triethylene glycoldimethacrylate(TEGDMA)	-1,6-bis(methacryl-ethyloxycarbonylamino)trimethyl hexane (UDMA)-Nonamethylenedioldimethacrylate (ND)
Physicalproperty	Sensitivity toambient light	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049	Similar but alldevices conformto therequirements ofISO 4049 andtherefore the
	Depth of cure	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049	requirements ofISO 4049 andtherefore the
	Flexuralstrength	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049	subjected deviceis substantiallyequivalent.
	Watersorption	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049
	Solubility	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049
	Colorstability	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049
	Radio-opacity	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO4049
Sterilization		Non-sterile	Non-sterile	Non-sterile	Identical
Shelf life		3 years at a temperaturebetween0.25°C (32.77F°)	3 years at a temperaturebetween0.25°C (32.77F°)	3 years at atemperature between0.25°C (32.77F°)	Identical

{6}------------------------------------------------

Shelf Life Testing

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

{7}------------------------------------------------

Material And Chemical Composition

The device does come into direct contact with the patient. However, all of the ingredients contained in OMNICHROMA FLOW BULK are used in Tokuyama Dental Corp.'s OMNICHROMA (K#173275), OMNICHROMA FLOW (K#193537), and ESTELITE FLOW QUICK High Flow (K#051808).

Performance Data Summary

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

A comparison of the OMNICHROMA FLOW BULK device with the predicate devices shown below:

		Subject device	Predicate #1	Predicate #2	Difference
Device name		OMNICHROMA FLOWBULK	ESTELITE BULK FILLFlow	OMNICHROMA FLOW	-
Physicalproperty	Sensitivity toambient light	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Similar but alldevices conformto therequirements ofISO 4049 andtherefore thesubjected deviceis substantiallyequivalent.
	Depth of cure	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049
	Flexuralstrength	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049
	Watersorption	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049
	Solubility	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049
	Colorstability	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049
	Radio-opacity	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049
Sterilization		Non-sterile	Non-sterile	Non-sterile	Identical
Shelf life		3 years at a temperaturebetween0-25°C (32-77F°)	3 years at a temperaturebetween0-25°C (32-77F°)	3 years at atemperature between0-25°C (32-77F°)	Identical

{8}------------------------------------------------

Conclusion

Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA FLOW BULK device in comparison to the predicate device identified above, and based on the biocompatibility of authorized devices with similar ingredients for the same use and additional biocompatibility testing, it is concluded that the OMNICHROMA FLOW BULK 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.