G-Fix is a light-cured resin cement for splinting mobile teeth. G-Fix is used in combination with phosphoric acid as a pre-treatment agent of tooth surfaces.

AI/ML Overview

This document describes the premarket notification for the device G-Fix, a light-cured resin cement for splinting mobile teeth. The study compares G-Fix to a legally marketed predicate device, GRADIA DIRECT Flo (UNIFIL FLOW), to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for G-Fix are based on ISO 4049:2009 (Dentistry - Polymer-based restorative materials) and ISO/TS 11405:2003 (Dentistry - Interaction of dental materials with hard tooth tissue - Principles for the assessment of biocompatibility). The table below summarizes the performance benchmarks, required specifications, and the test results for G-Fix and the predicate device.

Property	Standards	Requirements	G-Fix Test Results (Applicant Device)	Predicate Device Test Results (GRADIA DIRECT Flo (UNIFIL FLOW))	Compare to Standard	Compare to Predicate Device
Sensitivity to ambient light	ISO 4049: 2009 5.2.7 Sensitivity to ambient light	Remain physically homogeneous.	Conformed	Conformed	Equal	Equal
Depth of cure	ISO 4049: 2009 5.2.8 Depth of cure	Not less than 1.5 mm	5.7 (0.1) mm	3.0 (0.0) mm	Exceeds	Exceeds
Flexural strength	ISO 4049: 2009 5.2.9 Flexural strength	Greater than 80 MPa	94 (5) MPa	96 (3.2) MPa	Exceeds	Equal
Water sorption	ISO 4049: 2009 5.2.10 Water sorption and solubility	Less than 40 µg/mm³	35 (0.9) µg/mm³	35 (1.3) µg/mm³	Exceeds	Equal
Solubility	ISO 4049: 2009 5.2.10 Water sorption and solubility	Less than 7.5 µg/mm³	0.6 (0.1) µg/mm³	0.5 (0.1) µg/mm³	Exceeds	Equal
Color stability after irradiation and water sorption	ISO 4049: 2009 5.4 Color stability after irradiation and water sorption	No more than slight change in color	Conformed	Conformed	Equal	Equal
Adhesion to tooth structure (Enamel)	ISO/TS 11405: 2003 5.2.5 Shear bond strength	Greater than 5 MPa	29 (1) MPa	31 (2) MPa*	Equal	Equal

*This result was obtained by the combination with phosphoric acid.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of specimens for depth of cure, flexural strength, etc.). The results for properties like Depth of Cure, Flexural Strength, Water Sorption, Solubility, and Adhesion to Tooth Structure provide multiple individual measurements, suggesting that a sufficient number of samples were tested to achieve the reported mean and standard deviation.

The data provenance is from internal performance bench tests conducted by GC America Inc. The country of origin of the data is not specified directly, but GC America Inc. is based in Alsip, Illinois, USA. The tests are retrospective, as they were conducted to support the 510(k) submission.

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

This document does not involve a clinical study with human interpretation or diagnostic evaluation. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set. The ground truth for the performance tests is based on the specified international standards (ISO 4049:2009 and ISO/TS 11405:2003) and objective measurements performed in a laboratory setting.

4. Adjudication Method for the Test Set:

Not applicable, as this is a performance bench test study and not a clinical study involving human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a dental material, and the study focuses on its physical and chemical properties and biocompatibility, not on a diagnostic algorithm requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is not an AI/algorithm-based device. The study evaluates the standalone performance of the material itself through objective laboratory tests.

7. Type of Ground Truth Used:

The ground truth used for this study is based on established international standards and objective laboratory measurements (e.g., ISO 4049:2009 for physical properties, ISO/TS 11405:2003 for adhesion, and ISO 10993 series for biocompatibility). The results are quantitative and directly compared against the numerical requirements set forth by these standards.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI-based device, so there is no training set in the conventional sense. The "training" for the device's development would involve material science research and formulation, but not in the context of data used for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an algorithm. The development of the material (G-Fix) would have been guided by material science principles and existing knowledge of dental materials, with experimental validation for optimization, but this doesn't constitute a "training set" with established ground truth in the context of this request.

Summary

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

October 9, 2015

GC America Inc. Mr. Mark Heiss Director, Regulatory Affairs & Academics Affairs 3737 W. 127th Street Alsip, Illinois 60803

Re: K151541

Trade/Device Name: G- Fix Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: July 7, 2015 Received: July 8, 2015

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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): __K151541 Device Name: G-FIX Indications for Use:

1. Splinting mobile teeth
  Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

1. Submitter Information:
  GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Fax:	(708) 926-9100
Date Prepared:	June 8, 2015

2. Device Name:

Proprietary Name:	G-Fix
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 872.3690
Product Code:	EBF

Predicate Devices: 3.

Company	Device	510(k) No.	Date Cleared
GC America Inc.	GRADIA DIRECT Flo (UNIFIL FLOW)	K020342	03/28/2002

4. Description of Device:

G-Fix is a light-cured resin cement for splinting mobile teeth. G-Fix is used in combination with phosphoric acid as a pre-treatment agent of tooth surfaces.

న్. Indications for Use:

Splinting mobile teeth

6. Technological characteristics:

All the components of the applicant device, G-Fix, have already been used in the predicate device. The curing mechanism of the predicate is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator system.

7. Performance Bench Tests

It is confirmed that the device conforms to the required specifications of ISO 4049:2009 and ISO/TS 11405: 2003 and is suitable for its intended use. Performance testing includes:

Sensitivity to ambient light
Depth of cure
· Flexural strength
· Water sorption
· Solubility
Color stability after irradiation and water sorption
· Adhesion to tooth structure (Enamel)

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8. Packaging

One (1) Dental Composite Dispensing Syringe 2.7g (2.0mL), 2 dispensing tips (plastic type), 1 light protective cover

Dispensing tip package: 30 dispensing tips (plastic type), 2 light protective covers 30 dispensing tips (needle type), 2 light protective covers

1. Shades
  Clear and TC (Tooth Color)
1. Shelf Life Evaluation and Storage Conditions:
- Shelf Life 2 years i
- Recommended for optimal performance, store in a cool and dark place. 4-25°C (39.2 77.0°F)
1. Biocompatibility

Biocompatibility studies were conducted based on ISO 10993-1, 10993-5, and 10993-10 for cytotoxicity, sensitivity, and irritation.

Test	ISO standard	Results	Conclusion
Sensitivity	10993-10	As defined by the scoring system ofKligman, this is a Grade I reaction andthe test article is classified as havingweak allergenic potential.	Based on the criteria of the protocol, aGrade I sensitization rate is not consideredsignificant and the test article meets therequirements of the ISO 10993-10guidelines.
Cytotoxicity	10993-5	There was no biological reactivity of thecells exposed to the test article extract.The response obtained from the positiveand negative control article extractsconfirmed the suitability of the testsystem.	Based on the criteria of the protocol and theISO 10993-5 guidelines, the test articlemeets the requirements of the test and isnot considered to have a cytotoxic effect.
Irritation	10993-10	The test article sites did not show asignificantly greater biological reactionthan the sites injected with the controlarticle.	Based on the criteria of the protocol, the testarticle meets the requirements of the ISO10993-10 guidelines.

Results

In addition, according to ISO 10993-1, products currently on the market may be considered as it relates to product biocompatibility. There have been no major adverse events reported for G-Fix.

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	Property	Standards	Requirements	Test results		ComparetoStandard	ComparetoPredicateDevice
1	Sensitivity toambient light	ISO 4049: 20095.2.7 Sensitivityto ambient light	Remainphysicallyhomogeneous.	G-Fix: ClearLot No.1103011GConformed	GRADIA DIRECTFlo (UNIFILFLOW): A1Lot No. 1111211Conformed
2	Depth of cure	ISO 4049: 20095.2.8 Depth ofcure	Not less than1.5 mm	5.6 mm5.6 mm5.7 mm5.7 mm5.7 mm5.7(0.1) mm	3.0 mm3.0 mm2.9 mm3.0 mm3.0 mm3.0(0.0) mm	Exceeds	Exceeds
3	Flexuralstrength	ISO 4049: 20095.2.9 Flexuralstrength	Greater than80 MPa	100 MPa89 MPa99 MPa93 MPa90 Mpa94(5) MPa	96 MPa101 MPa99 MPa93 MPa93 Mpa96(3.2) MPa	Exceeds	Equal
4	Watersorption	ISO 4049: 20095.2.10 Watersorption andsolubility	Less than 40µg/mm³	36.1 µg/mm³33.9 µg/mm³34.4 µg/mm³33.5 µg/mm³34.6 µg/mm³35(0.9) µg/mm³	33.1 µg/mm³,35.4 µg/mm³,36.7 µg/mm³,34.0 µg/mm³,33.9 µg/mm³35(1.3) µg/mm³	Exceeds	Equal
5	Solubility	ISO 4049: 20095.2.10 Watersorption andsolubility	Less than 7.5µg/mm³	0.8 µg/mm³0.4 µg/mm³0.6µg/mm³0.7µg/mm³0.7µg/mm³0.6(0.1) µg/mm³	0.5 µg/mm³0.5 µg/mm³0.4 µg/mm³0.6 µg/mm³0.7 µg/mm³0.5(0.1)µg/mm³	Exceeds	Equal
6	Color stabilityafterirradiationand watersorption	ISO 4049: 20095.4 Colorstability afterirradiation andwater sorption	No more thanslight changein color	Conformed	Conformed	Equal	Equal
7	Adhesion totoothstructure(Enamel)	ISO/TS 11405:2003 5.2.5Shear bondstrength	Greater than5MPa	31 MPa29 MPa28 MPa30 MPa27 Mpa29(1) MPa	34 MPa31 MPa29 MPa28 MPa32 MPa31(2) MPa*This result wasobtained by thecombination withphosphoric acid	Equal	Equal

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	Applicant device	Comparative device
Trade name	G-Fix	GRADIA DIRECT Flo (UNIFIL FLOW)
Common Name	Light-cured resin cement for splinting mobile teeth	Light-cured Flowable composite restorative	Different*
ProductClassification	Tooth Shade Resin Material	Tooth Shade Resin Material	Same
Company	GC Corporation	GC Corporation	Same
510(k) No.	-	K020342
Indications for use	1. Splinting mobile teeth	1. Restoration of class I, II, III, IV, V cavities2. Restoration of root surface caries3. Restorations in deciduous teeth4. Filling tunnel shaped cavities5. Sealing hypersensitive areas6. Liner / base / filling in cavity undercuts7. Sealant8. Fixing mobile teeth9. Additions to composite restorations	DifferentNote: #8 ofComparitiveDevice issame asapplicant.
Productdescription	G-Fix is a visible-light-cured resin cement for fixingsplinting mobile teeth . G-Fix is used incombination with phosphoric acid as apre-treatment agent of tooth surfaces.	GRADIA DIRECT Flo (UNIFIL FLOW) is a light curedhighly flowable composite filled in a dental syringe.The material is available in 7 shades.	Both light curedPolymer basedmaterial
Components	* Barium glass* Urethane dimethacrylate (UDMA)* Bisphenol A polyethoxy methacrylate(Bis-MEPP)* Phosphoric ester monomer* Silicon dioxide* Photo initiator* Pigment	* Fluoro-alumino-silicate glass* Urethane dimethacrylate (UDMA)* Dimethacrylate* Silicon dioxide* Photo initiator* Pigment	Components ofnew device arecontained inpredicate anddevice includesPhosphoricmonomer that iscommon in thisdevice type
Instructions for use	1. Preparations2. Shade Selection3. Preparation in case of tooth structure (applyphosphoric acid to the bonding surfaces of teeth for30 seconds)4. Preparation in case of restoration5. Placement of G-Fix6. Light Curing7. Finishing and Polishing	1. Shade Selection2. Cavity Preparation3. Bonding treatment4. Placement of GRADIA DIRECT Flo (UNIFIL Flo)5. Light Curing6. Finishing and Polishing	Different in thatthe indicationsare narrowerthan thepredicate
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Substantial equivalence:

The applicant device comples with the requirements of ISO 4049: 2009 (Dentisty - Polymer-based restorative materials) and ISO/TS 11405: 2003. The curing mechanism of the new and predicationially equivalent in principle. Therefore, the new and predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device are substantially equivalent to the predicate devices. Components of the new device are commonly used in other restorative materials.

The applicant device shows one indication with predicate device which is "splinting mobile teeth."

Differences

Common Name - G-Fix description is different from predicate device even though product classification is the same.

The Indications for Use is different as clinically the product is used to splint teeth.

Comparison to performance and predicate device have been met or exceeded.

Product description is different as clinically this product is used to splint teeth (predicate is more general as a restorative).

Components - additional use of Bis-MEPP is to modify viscosity as use for splinting teeth. Phosphoric ester monomer added to allow for adhesion to enamel.

Instructions for Use is different as clinically the product is used to splint teeth (predicate is more general as a restorative).

Technological characteristics:

All the components of the applicant device, G-Fix, have already been used in the predicate is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator system.

Use of 10-MDP (phosphoric ester monomer) allows for adhesion to tooth structure without the of dentin adhesive.

Conclusion

Based on formulation, testing and meeting and/or exceeding ISO standards related to performance, as well as meeting at least equivalence versus the predicate device, we find the applicant device to be substantially equivalent.

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.