GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures. GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material. Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the GC Fit Checker Advanced device:

Acceptance Criteria and Device Performance Study for GC Fit Checker Advanced

This 510(k) summary focuses on demonstrating that the GC Fit Checker Advanced, a dental impression material, is substantially equivalent to existing predicate devices. The study conducted is a bench study evaluating physical properties directly related to the material's function.

1. Table of Acceptance Criteria and Reported Device Performance

Specification	Acceptance Criteria (Requirement)	GC Fit Checker Advanced (Test Results)	GC Fit Checker II (Predicate Device)	Meets Acceptance Criteria?
Detail Reproduction (μm)	≤ 20 μm	20, 20, 20 μm (reported as three measurements)	20, 20, 20 μm	Yes
Elastic Recovery (%)	≥ 96.5%	98.9 – 99.3%	98.5 – 99.6%	Yes
Strain in Compression (%)	2.0 – 20%	4.2 – 4.5%	6.1 – 6.5%	Yes

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

Sample Size: The document does not explicitly state the numerical sample size (n) for each test. However, for "Detail reproduction," three measurements are reported (20, 20, 20), suggesting at least 3 samples were tested. For "Elastic recovery" and "Strain in compression," ranges are provided, which typically come from multiple measurements but the exact number isn't quantified.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a bench test of a newly developed material by GC America Inc., it's implied to be prospective and likely conducted in-house or by a contracted lab.

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

This type of information is not applicable to this study. The "ground truth" for these physical property tests is based on objective, quantifiable measurements using standardized test methods (ISO 4823), not on expert subjective assessment. Therefore, no human experts were involved in establishing the "ground truth" for the test set.

4. Adjudication Method for the Test Set

This information is not applicable to this study. Since the ground truth is established through objective physical measurements as per ISO standards, there is no need for an adjudication method by human experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a bench study on the physical properties of a material, not a clinical study involving human readers or cases.

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

This concept is not applicable to this device. GC Fit Checker Advanced is a physical dental impression material, not an AI algorithm or software device. The performance evaluation is entirely standalone, as it's the material itself performing under predefined conditions.

7. The Type of Ground Truth Used

The ground truth used for this study is based on objective measurements derived from standardized international testing methods (ISO 4823). These standards define how to quantitatively measure properties like detail reproduction, elastic recovery, and strain in compression, providing a clear, reproducible ground truth.

8. The Sample Size for the Training Set

This concept is not applicable to this device. GC Fit Checker Advanced is a physical material, not a machine learning model. Therefore, there is no "training set." The product's development likely involved iterative formulation and testing, but not in the context of an AI training set.

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

This concept is not applicable as there is no training set for a physical dental material.

Summary

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Section 6 - 510(k) Summary

K110871

Submitter Information: 1.

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

March 24, 2010 Date Prepared:

Device Name: 2.

Proprietary Name:	GC Fit Checker Advanced
Classification Name:	Dental Impression material
Device Classification:	872.3660
Product Code:	ELW

Substantial equivalence for the medical device is based on comparison to the following devices:

Product	Applicant	510(k) No.	Code No.
Fit Checker II	GC AMERICA, INC	K032289	ELW
GC Fusion Fast (Exa'lence)*	GC AMERICA, INC	K043471	ELW
GC Fusion (Exa'lence)*	GC AMERICA, INC	K041398	ELW
HYDROFLEX	GC AMERICA, INC	K973343	ELW

Due to trademark issues, product was renamed Exa'lence from Fusion/Senn. FDA notified August 18, 2009.

1. Device description and Intended Use
  GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures.
1. Components and Mode of Action
  GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material.

Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'Lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease. This product reduces your stress during the fit checking process which is usually done repeatedly until a good fit is achieved.

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5. Description of Safety and Substantial Equivalence

The applicant device, Fit Checker Advanced is equivalent to the predicate device, GC Fit Checker II, in its intended use. The applicant device, Fit Checker Advanced, is equivalent to the predicate device, EXA'lence Extra Light Body Regular set in its chemical composition.

5. Performance

1) Summary of Performance Specifications

	Specification	Test method applied	Test results		Requirement	Conforms
			GC Fit CheckerAdvanced	GC FitChecker II
1	Detailreproduction(μm)	Detail reproductionwas measured by thedetail reproductiontest method in ISO4823	202020	202020	20μm	Yes
2	Elasticrecovery(%)	Elastic recovery wasmeasured by theElastic recovery testmethod in ISO4823	98.9 – 99.3	98.5 – 99.6	≥96.5	Yes
3	Strain inCompression(%)	Strain in compressionwas measured by theStrain in compressiontest method in ISO4823	4.2 – 4.5	6.1 – 6.5	2.0-20	Yes

As described above, the applicant device, GC Fit Checker Advanced is substantially equivalent to comparative devices, such as GC Fit Checker II and EXA'lence.

4. Shelf Life Evaluation and Storage Conditions:

Shelf Life 2 years -
Store in a cool and dark place. 4-25°C (39.2-77.0°F) -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Mark Heiss, DDS Director -Academic and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

JUN 1 7 2011

Re: K110871

Trade/Device Name: GC Fit Checker Advanced Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 24, 2011 Received: March 29, 2011

Dear Dr. 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 - Dr. 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/ucm 115809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony O.m

Chilhony 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

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Section 5 - Indications for Use Statement

Indications for Use

11/087 510(k) Number (if known):

Device Name:_GC Fit Checker Advanced

Indications for Use:

Checking fit of crowns, bridges, veneers, inlays and dentures.

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 Dunne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110871

Page 5.1 of 5.1

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).