GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.

AI/ML Overview

The provided document is a 510(k) summary for the GC Fuji Triage EP dental cement. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information typically found in a clinical study report that would outline acceptance criteria, study design, and results for a medical device with an algorithmic component.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they are not present in the provided text. The document describes a non-clinical performance testing for a dental cement, not a study involving human readers or AI algorithms.

Here's why each point of your request cannot be answered based on the provided text:

A table of acceptance criteria and the reported device performance: While there is a table of "Property" and "Requirements" for non-clinical performance (e.g., Net setting time, Compressive strength), this is for the physical properties of the dental cement, not the performance of an AI device. The document explicitly states "No clinical testing has been performed on this device."
Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no test set for an AI device, and thus no ground truth established by experts in that context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No MRMC study was performed as this is a dental cement, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. The ground truth for the dental cement is based on laboratory-measured physical properties against ISO standards.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

The document pertains to the regulatory submission for a dental cement, GC Fuji Triage EP, and focuses on demonstrating its safety and efficacy through biocompatibility testing (ISO 10993-1:2018, ISO 10993-5, ISO 10993-10) and physical property testing against ISO 9917-1:2007 for water-based cements, as well as comparison to a predicate device for substantial equivalence.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

July 2, 2020

GC America Inc. Mark Heiss Director, Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60780-3

Re: K193484

Trade/Device Name: GC Fuji Triage EP Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: June 2, 2020 Received: June 5, 2020

Dear Mark Heiss:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN
SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name GC Fuji Triage EP

Indications for Use (Describe)

Pit & Fissure Sealant and Root Surface Sealant
Hypersensitivity due to abrasion and early non-cavitated lesions
Protection immature enamel
Temporary filling including endodontic access

Type of Use (Select one or both, as applicable) 2 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."

FORM FDA 3881 (7/17)

Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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

Image /page/3/Picture/0 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color and appear to be slightly italicized or slanted to the right. There are single quotation marks on either side of the letters.

Image /page/3/Picture/1 description: The image shows a graphic design with a minimalist and abstract style. On the left side, there is a partial outline of a triangle, represented by a single line. To the right of the triangle, there is a cluster of seven small, tilted rectangles arranged in a pattern that resembles a scattered or ascending formation. The color of both the triangle outline and the rectangles is a teal or turquoise shade, set against a white background.

510(k) Summary 1

Submitter Information:GC America Inc.3737 W. 127th StreetAlsip, IL 60803
Contact Person:Phone:Alternate Contact:Phone:Fax:	Mark Heiss, D.D.S.(708) 926-3090Lori Rietman(708) 926-3092(708) 925-0373
Date Prepared:	June 30, 2020
1. Device Name:Proprietary Name:Classification Name:Device Classification:	GC Fuji Triage EPConventional Glass Ionomer CementClass II, 872.3275

EMA

1. Predicate Devices:
  Product Code:

Product	Applicant	510(k) No.	Code No	Predicate	Decision Date
GC Fuji Triage	GC America Inc.	K013198	EMA	Primary	10/29/2001
MI VARNISH	GC America Inc.	K102808	LBH	Reference	12/22/2010

1. Description of Device:
  GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.

GC Fuji Triage EP Package: Capsule (Powder 0.30g/Liquid 0.15g) - QTY: 50

Shades available: Pink, White

Shelf Life and Storage Conditions:

Shelf Life 2 years -
-Recommended for optimal performance, store in a cool and dark place. 4-25℃ (39 - 77°F)
1. Performance Bench Tests:

It is confirmed that the device conforms to the required specifications of ISO 9917-1:2007.

న్. Non-Clinical Performance Testing:

A biocompatibility assessment was completed according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

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

Cytotoxicity (L929 MEM Elution Test)

Based on the criteria of the protocol of ISO 10993-5

Sensitivity (Kligman Maximization Test)

Based on the criteria of the protocol of ISO 10993-10

Irritation (Intracutaneous Injection Test)

Based on the criteria of the protocol of ISO 10993-10

GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative and does come in contact with body tissues (tooth - enamel, dentin) for more than 30 days

In conclusion, biocompatibility of GC Fuji Triage EP is acceptable device from the biological evaluation result.

It is confirmed that the device conforms to the required specifications of ISO 9917-1: 2007 Dentistry -Water-based cements - Part 1: Powder/liquid acid-base cements and company standard is suitable for its intended use. Performance testing includes:

	Property	Requirements
1	Net setting time	1.5 to 6 min
2	Compressive strength	More than 100 MPa
3	Acid erosion	Less than 0.17 mm
4	Optical properties (opacity)	0.35 to 0.90
5	Optical properties (color)	Match the nominated shade guide
6	Acid-soluble lead content	Less than 100mg/kg
7	Radiopacity	More than equivalent thickness of aluminum

6. Clinical Performance Testing

No clinical testing has been performed on this device.

7. Comparison of Technology:

The hardening mechanism of GC Fuji Triage EP and GC Fuji Triage are substantially equivalent in principle. Thus, the applicant device and the predicate device are the same in function and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

The following differences may be noted between GC Fuji Triage EP and the predicate devices:

GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide amorphous calcium phosphate) in ● the formulation.
GC Fuji Triage EP includes the elongation tip.
The applicant device, Fuji Triage EP, is a glass ionomer cement while MI VARNISH is a topical fluoride varnish.

8. Conclusion

The applicant device, GC Fuji Triage EP, is substantially equivalent in qualitative features to the comparative device, FUJI Triage.

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

	Applicant Device	Primary Device	Reference Device
	GC Fuji Triage EP	FUJI TriageK013198	MI VARNISHK102808
Trade name	GC Fuji Triage EP	FUJI TriageK013198	MI VARNISHK102808
Manufacturer	GC Corporation	GC Corporation	GC Corporation
Productcategory	Restorative glass ionomer cement	Restorative glass ionomer cement	Topical fluoride varnish
Powder/Liquidratio	Powder 0.30g/Liquid 0.15g	Powder 0.30g/Liquid 0.15g	Not applicable
Indications forUse	1. Pit & Fissure Sealant and Root Surface Sealant2. Hypersensitivity due to abrasion and early non-cavitated lesions3. Protection immature enamel4. Temporary filling including endodontic access	1. Pit and fissure sealant.2. Treatment of early non-cavitated lesions; suchas tooth brush abrasion and root surfacesensitivity3. Intermediate restorative material4. Temporary filling of endodontic access.	Treatment of hypersensitive teeth.
Productdescription	The Device consists of powder and liquid and filled in acapsule. The mixed cement sets by acid-base reaction offluoro-alumino-silicate glass and polyacrylic acid.	The device consists of powder and liquid andfilled in a capsule. The mixed cement sets byacid-base reaction of fluoro-alumino-silicateglass and polyacrylic acid.	The device is a 5% sodium fluoridevarnish that a desensitizing actionwhen applied to tooth surfaces. Theapplication leaves a film of varnish ontooth surfaces.
TechnologicalCharacteristicsand Mode ofaction	GC Fuji Triage EP contains CPP-ACP (caseinphosphopeptide - amorphous calcium phosphate).CPP-ACP was added to moderate the strength ofcement for the use as more temporary or provisionalrestoration material. CPP-ACP was chosen as theadditive for regulating the strength because it does notinhibit the setting reaction of the material while can tonedown the physical strength.Aluminum ion, Strontium ion and Fluoride ion arereleased from Fluoro-alumino-silicate glass due to thisreaction. Of these ions, Aluminum ion and Strontium ioncrosslink the polyacrylic acid and form hydrogel.Fluoride ion doesn't react, it remains inside hydrogel asion. This material set by the above reaction. The setmaterial contains fluoride ion inside as free ion. Theseions can be gradually release from the setting materialin very small amounts with time.	GC Fuji Triage Capsule is radiopaque glassionomer protection and temporary restorativematerial in capsules consisting of powder andliquid. The powder is Fluoro-alumino-silicateglass and liquid is Polyacrylic acid solution.They are mixed with an electrical capsule mixerand applied directly to a cavity with a capsuleapplier. Aluminum ion, Strontium ion andFluoride ion are released from Fluoro-alumino-silicate glass due to this reaction. Of these ions,Aluminum ion and Strontium ion crosslink thepolyacrylic acid and form hydrogel. Fluoride iondoesn't react, it remains inside hydrogel as ion.This material set by the above reaction. The setmaterial contains fluoride ion inside as free ion.These ions can be gradually release from thesetting material in very small amounts with time.	MI Varnish is a paste formuladelivered in unit dose package. Thelaminating film lid is peeled off andthe paste is applied on the toothsurface with a disposable brush. Thedevice is a 5% sodium fluoridevarnish and also contains CPP-ACP(casein phosphopeptide -amorphous calcium phosphate) inthe formula. When the device isapplied on the tooth surface, a thinfilm of varnish is left on the toothsurface by evaporation of ethanol ontooth. The film is composed bypolyvinyl acetate as film former andhydrogenated rosin as adhesives.The film works for desensitizing ofthe tooth surface.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.