GC Fuji TEMP is a 2-paste type, glass ionomer provisional luting cement filled in separate syringes, and assembled in one cartridge. With use of Paste Pak Dispenser, GC Fuji TEMP can be dispensed with the appropriate paste ratio.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the GC Fuji Temp device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Standards / Requirements	Reported Device Performance
Appearance	• Free from extraneous material • Homogeneous and smoothly consistent (ISO 9917-1: 2007)	Within spec set by standard
Film thickness	Less than 25µm (ISO 3107: 2004)	Within spec set by standard
Setting time	4 to 10 min (ISO 3107: 2004)	Within spec set by standard
Compressive strength	Less than 35MPa (ISO 3107: 2004)	Within spec set by standard
Acid-soluble lead content (1st test)	Less than 0.40mm (ISO 9917-1: 2007)	Within spec set by standard
Acid-soluble lead content (2nd test)	Less than 100mg/kg (ISO 9917-1: 2007)	Within spec set by standard
Radiopacity	More than equivalent thickness of aluminum (ISO 9917-1: 2007)	Within spec set by standard
Working time	2min30sec - 3min30sec (given by the manufacturer via Company Specification: AB-15-Q-301-493)	Within spec set by standard
Color	Equivalent to standard sample (given by the manufacturer via Company Specification: AB-15-Q-301-493)	Within spec set by standard
Consistency	27 – 37 mm (given by the manufacturer via Company Specification: AB-15-Q-301-493)	Within spec set by standard

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

The sample sizes for the test set vary by property:

Appearance: Visual inspection (no specific N given, but implied for each paste before/after mixing).
Film thickness: N=5
Setting time: N=2
Compressive strength: N=5
Acid-soluble lead content (first test): N=5
Acid-soluble lead content (second test): N=1
Radiopacity: N=1
Working time: Not explicitly stated, derived from "mixed cement becomes rubbery."
Color: Not explicitly stated, derived from "Comparing set cement with standard sample."
Consistency: Not explicitly stated, but 0.5 mL of mixed cement is loaded.

Data Provenance: The document does not explicitly state the country of origin. It appears to be an internal company study ("Company Specification: AB-15-Q-301-493" and "Company Specification AB-15-Q-301-493" are mentioned). The study is retrospective in the sense that the results are presented as already obtained and summarized for FDA submission; it's a report of testing, not a protocol for future prospective testing.

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

This information is not provided in the document. The tests are based on engineering standards (ISO) and company specifications, which rely on measurable physical properties rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective physical property measurements, not subjective evaluations that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a dental cement, and its evaluation focuses on physical and chemical properties.

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

Yes, the studies described are standalone performance tests of the dental cement itself, without any human-in-the-loop component. The "device" in this context is the physical cement, not a digital algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for these tests are the established requirements and specifications set forth by international standards (ISO) and company internal specifications. These standards define acceptable ranges for physical and chemical properties (e.g., film thickness, setting time, compressive strength, acid-soluble lead content, radiopacity, working time, color, consistency).

8. The Sample Size for the Training Set

This information is not applicable/not provided. The product is a physical dental cement, not a machine learning model, so there is no "training set" in the conventional sense. The "training" for the product would be the formulation and material science development, but this document focuses on final product testing.

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

This information is not applicable/not provided for the reasons stated above.

Summary

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K101420

SEP 1 7 2010

GC AMERICA INC. 3737 WEST 127TH STREET ALSIP, ILLINOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103

Section 6 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Information: ﻬﻨ

GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 897-4042
Fax:	(708) 897-4031

Date Prepared: April 14, 2010

2. Device Name:

Proprietary Name:	GC Fuji Temp
Classification Name:	Dental Cement
Device Classification:	Class II, 872.3275
Product Code:	EMA

Predicate Devices: 3.

Company	Device	510(k) No.	DateCleared
GC America Inc.	Fuji I	K980695	4/13/98
GC America Inc.	Freegenol Temporary Pack	K842994	10/18/84

Description of Device: 4.

The applicant device, GC Fuji TEMP is substantially equivalent to the predicate devices in its intended use. Fuii I is intended for final cementation. Freegenol Temporary Pack is intended for temporary cementation. Although the intended periods in oral are different, all devices are used as luting cements.

5. Indications for Use:

· Temporary cementation of crowns and bridges
· Provisional cementation of crowns and bridges on implant abutments
Technological characteristics: ్.

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GC Fuji TEMP Paste A contains Fluoro-alumino silicate glass (Forming ionic bond with polyacylic acid, and provides radiopacity and fluoride release), distilled water, viscosity modifying agents, anti-septic and pigments. Paste B contains distilled water, Polyacrylic acid (Forming ionic bond with fluoroalumino-silicate glass and calcium contained in tooth structure), radiopacity agent, pH adjusting agent, and viscosity modifying agents.

7. Summary of Physical tests:

ﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

List of Standards used/results

*ISO 3107: 2004 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements * ISO 9917-1: 2007 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base coments * Company Specification: AB-15-Q-301-493

	Property	Standards	Test methods	Requirements	Result-qualitative
1	Appearance	ISO 9917-1: 2007 5Material	Visually inspectedbefore and after pastemixing	• Free fromextraneousmaterial• Homogeneousand smoothlyconsistent	Within specset bystandard
2	Filmthickness	ISO 3107: 2004Dentistry - Zincoxide/eugenol andzinc oxide/non-eugenol cements,Section 6.4Determination of filmthickness	(150 (+/-) 2) N load isapplied for 10 min, 90sec after start of mix(N=5)	Less than 25µm	Within specset bystandard
3	Setting time	ISO 3107: 2004Dentistry - Zincoxide/eugenol andzinc oxide/non-eugenol cements,Section 6.2Determination ofsetting time	Mixed cement isplaced at 37 deg, 180sec after end of mix.The time whenneedle fails topenetrate completely2mm depth of cementis defined, countingfrom start of mix.(N=2)	4 to 10 min	Within specset bystandard
4	Compressivestrength	ISO 3107: 2004Dentistry - Zincoxide/eugenol andzinc oxide/non-eugenol cements,Section 6.3Determination ofcompressive strength	Specimens (6mmhigh, 4mm indiameter)compressed at1mm/min (N=5)	Less than 35MPa	Within specset bystandard
5	Acid-solublelead content	ISO 9917-1: 2007Dentistry - Water-based cements -- Part1: Powder/liquid,Section 13.2 Acid-soluble lead content	Soaked in lactic acidsolution (pH 2.74) for24 hours. (N=5)	Less than 0.40mm	Within specset bystandard

Table 8.1.1 Test standards and methods based on ISO standards

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6	Acid-solublelead content	ISO 9917-1: 2007Dentistry - Water-based cements - Part1: Powder/liquid,Section 13.2 Acid-soluble lead content	Crushed cement aftersetting is soaked indiluted HCI solutionfor 16 hours. Elutedlead is detected byatomic absorption orequivalent method.(N=1)	Less than100mg/kg	Within specset bystandard
7	Radiopacity	ISO 9917-1: 2007Dentistry - Water-based cements - Part1: Powder/liquid,Section 14Radiopacity	Compared toaluminum (N=1)	More thanequivalentthickness ofaluminum	Within specset bystandard

*ISO 3107:2004 is referred in consideration of clinical use of GC Fuji TEMP, which is relatively used for temporary, although the formulation of GC Fuji TEMP doesn't belong to zinc oxide/eugenol or zinc oxide/non-eugenol coments.

*ISQ 9917-1: 2007 is referred in consideration of the formulation of GC Fuji TEMP, which is based on glass polyalkenoate. In that requirement, acid erosion for glass polyalkenoate coments is "Max. 0.17 mm". However, in view of provisional cementation, the criteria for zinc polycarboxylate cements are adopted.

	Property	Standards andtest methodsapplied	Test method	Requirements
1	Workingtime	CompanySpecification: AB-15-Q-301-493	The time when mixedcement becomes rubberyis defined as workingtime (from start of mix).	2min30sec -3min30sec(given by themanufacturer)	Within spec setby standard
2	Color	CompanySpecification: AB-15-Q-301-493	Comparing set cementwith standard sample	Equivalent tostandard sample	Within spec setby standard
3	Consistency	CompanySpecification AB-15-Q-301-493	0.5 mL of mixed cementis Loaded with 120g for10 minutes. Average oflong axis and short axisare calculated.	27 – 37 mm(given by themanufacturer)	Within spec setby standard

Description of Safety and Substantial Equivalence: ----- 8.

All the components of the applicant device, GC Fuji Temp, have already been used in the predicate devices which are legally marked for the same indications and the same type of tissue contact. This supports the compatibility of GC Fuji Temp and the safety of the applicant device is substantially equivalent to the predicate devices. The new device and predicate devices are similar in function, composition, and intended use.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle are three stylized human figures, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Mark Heiss Director, New Business Development, Academic & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

... •

Re: K101420

SEP 1 7 2010

Trade/Device Name: GC Fuji Temp Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 24, 2010 Received: August 25, 2010

Dear Mr. 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. 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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Page 2- Mr. Heiss

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5

Indications for Use

SEP 1 7 2010

510(k) Number (if known):

GC Fuji TEMP Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Temporary cementation of crowns and bridges ●
Provisional cementation of crowns and bridges on implant abutments ●

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Division of Anestheslology, General Devices Division of Anesthesionogy .
Infection Control, Dental Devices KIDIYAD

510(k) Number: ر

Page 5.1 of 5.1

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.