The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.

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

AI/ML Overview

The provided text describes the 510(k) premarket notification for the OMNICHROMA tooth shade resin material. It does not contain information about a comparative effectiveness study involving AI or human readers, nor does it detail acceptance criteria and performance data in the context of an AI device. The document is for a dental restorative material, not an AI-powered diagnostic or assistive device.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to an AI device.
Sample sizes, data provenance, and expert details for a test set for an AI device.
Adjudication methods for an AI device's test set.
MRMC study details or effect sizes for human readers with/without AI assistance.
Standalone performance for an AI algorithm.
Ground truth types in the context of AI.
Training set sample size and ground truth establishment for an AI device.

The provided document focuses on the physical and chemical properties of a dental resin and its substantial equivalence to a predicate device based on non-clinical testing according to ISO 4049. There is no mention of AI, diagnostic performance, or human reader studies.

Summary

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February 27, 2018

Tokuyama Dental Corporation % Keith Barritt Fish & Richardson P.C. 901 15th Street, Suite 700 Washington, District of Columbia 20005

Re: K173275

Trade/Device Name: OMNICHROMA Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 28, 2017 Received: November 29, 2017

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.

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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 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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.

Andrew I. Steen -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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Indications for Use

510(k) Number (if known) K173275

Device Name

OMNICHROMA

Indications for Use (Describe)

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

Direct anterior and posterior restorations
Direct bonded composite veneer
Diastema closure
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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K173275

510(k) Summary Tokuyama Dental Corporation OMNICHROMA dental 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, Suite 700 Washington, DC 20005 (202) 783-5070 Phone: Facsimile: (202) 783-2331 barritt@fr.com Email:

(iii) Preparation Date

February 26, 2018

De vice

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

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Predicate Device

Primary Predicate: Tokuyama Dental Corporation's PALFIQUE ESTELITE LV CLEAR (K#010267).

Reference Devices: Kuraray's CLEARFIL MAJESTY ES-2 (K#121583); Heraeus Kulzer's VENUS PEARL (K#112501); Tokuyama Dental Corporation's ESTELITE SIGMA QUICK (K#080940); Tokuyama Dental Corporation's ESTELITE FLOW QUICK (K#051808); and Tokuyama Dental Corporation's ESTELITE BULK FILL FLOW (K#161353)

De vice Description

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
Direct bonded composite veneer
Diastema closure
Repair of porcelain/composite

Comparison of Technological Characteristics

The OMNICHROMA device does not have its own energy source. There are no accessories provide with the device. The OMNICHROMA device has the same basic technological characteristics in terms of design, material, and chemical composition as the primary predicate device as shown below:

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		Subject device	Primary predicate	Difference
Device name		OMNICHROMA	Palfique Estelite LV Clear	-
Manufacturer		Tokuyama Dental	Tokuyama Dental	-
510(k) No.		K173275	K010267	-
Classification name		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- Direct bonded compositeveneer- Diastema closure- Repair ofporcelain/composite	For use as a tooth shaderesin material in dentalprocedures.	Indications fornew device arewithin those ofthe predicate
Component	Container	Syringe or Pre-loaded tip	Syringe	Use of pre-loadedtip
	Shade	1 shade	1 shade	-
Principle of operation		Tooth shade resin materialthat is cured by photopolymerization. (Light-cure)	Tooth shade resin materialthat is cured by photopolymerization. (Light-cure)	-
Material	Filler	- Silica-zirconia filler- Composite filler	- Silica-titania filler	As all of theingredients in thesubject devicehave alreadybeen authorizedby FDA for usein similar devices
	Resin matrix monomer	- 1,6-bis(methacryl-ethyloxycarbonylamino)trimethylhexane (UDMA)- Triethylene glycoldimethacrylate(TEGDMA)	- Methacrylates
Physical property	Sensitivity to ambient light	Conformed to therequirement of ISO 4049	Conformed to therequirement of ISO 4049	Conformance tostandard; specificmeasurementsmay vary slightly
	Depth of cure	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials
	Flexural strength	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials
	Water sorption	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials
	Solubility	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials
	Color stability	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials
	Radio- opacity	Conformed to therequirement of ISO 4049Dentistry -- Polymer-based restorative materials	-
Sterilization		Non-sterile	Non-sterile

Comparison of OMNICHROMA device with the primary predicate device

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Performance Data Summary

Non-clinical testing of the physical properties of the OMNICHROMA device was conducted in accordance with ISO 4049:2009. which specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The polymer-based luting materials covered by ISO 4049:2009 are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.

There were no clinical tests performed for the OMNICHROMA device.

Conclusion

Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA 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 OMNICHROMA device is substantially equivalent to the predicate device.

41318781.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.