Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and physical performance of a resin cement, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a resin cement used for splinting mobile teeth, which is a restorative procedure to stabilize teeth, not to treat a disease or condition in a therapeutic manner.

Diagnostic

No
The device is described as a light-cured resin cement for splinting mobile teeth, indicating a therapeutic or restorative function rather than a diagnostic one. Its intended use is to "Splinting mobile teeth," which is a treatment not a diagnosis. The performance studies focus on material properties relevant to its function as a cement (e.g., depth of cure, flexural strength, adhesion), not its ability to identify or characterize medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "light-cured resin cement," which is a physical material, not software. The performance studies also focus on material properties and biocompatibility, further indicating it is a physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "Splinting mobile teeth." This is a therapeutic or restorative procedure, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: G-Fix is a "light-cured resin cement." This describes a material used for bonding or fixing, not for analyzing biological samples.
Performance Studies: The performance studies focus on material properties like "Sensitivity to ambient light, Depth of cure, Flexural strength, Water sorption, Solubility, Color stability after irradiation and water sorption, and Adhesion to tooth structure (Enamel)." These are relevant to the physical and chemical performance of a dental material, not to diagnostic accuracy.
Key Metrics: The "Not Found" for key metrics like Sensitivity, Specificity, PPV, and NPV further indicates that this is not a diagnostic device. These metrics are crucial for evaluating the performance of IVDs.

In summary, G-Fix is a dental material used for a therapeutic purpose (splinting teeth), and its performance is evaluated based on its physical and chemical properties, not its ability to diagnose a condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. Splinting mobile teeth

Product codes (comma separated list FDA assigned to the subject device)

EBF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth surfaces

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)

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

Sensitivity (ISO 10993-10): Grade I reaction, weak allergenic potential. Meets requirements.
Cytotoxicity (ISO 10993-5): No biological reactivity of cells to test article extract. Meets requirements, not considered to have a cytotoxic effect.
Irritation (ISO 10993-10): Test article sites did not show a significantly greater biological reaction than control. Meets requirements.

Comparison to Standard and Predicate Device:

Sensitivity to ambient light: Conformed for G-Fix and Predicate. Equal to Standard.
Depth of cure: 5.7(0.1) mm for G-Fix; 3.0(0.0) mm for Predicate. Exceeds standard (Not less than 1.5 mm). Exceeds Predicate.
Flexural strength: 94(5) MPa for G-Fix; 96(3.2) MPa for Predicate. Exceeds standard (Greater than 80 MPa). Equal to Predicate.
Water sorption: 35(0.9) µg/mm³ for G-Fix; 35(1.3) µg/mm³ for Predicate. Exceeds standard (Less than 40 µg/mm³). Equal to Predicate.
Solubility: 0.6(0.1) µg/mm³ for G-Fix; 0.5(0.1)µg/mm³ for Predicate. Exceeds standard (Less than 7.5 µg/mm³). Equal to Predicate.
Color stability after irradiation and water sorption: Conformed for G-Fix and Predicate. Equal to Standard.
Adhesion to tooth structure (Enamel): 29(1) MPa for G-Fix; 31(2) MPa for Predicate. Equal to standard (Greater than 5MPa). Equal to Predicate (This result was obtained by the combination with phosphoric acid).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. Performance metrics were given for physical properties and biocompatibility.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K020342

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing to the right, stacked on top of each other. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.

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.

1

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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Image /page/3/Picture/0 description: The image shows the green text "'CC'" on a white background. The text is stylized with the letters "CC" being larger than the apostrophes. The apostrophes are also slanted. The text is in a sans-serif font.

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)

4

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
Sensitivity	10993-10	As defined by the scoring system of
Kligman, this is a Grade I reaction and
the test article is classified as having
weak allergenic potential.	Based on the criteria of the protocol, a
Grade I sensitization rate is not considered
significant and the test article meets the
requirements of the ISO 10993-10
guidelines.
Cytotoxicity	10993-5	There was no biological reactivity of the
cells exposed to the test article extract.
The response obtained from the positive
and negative control article extracts
confirmed the suitability of the test
system.	Based on the criteria of the protocol and the
ISO 10993-5 guidelines, the test article
meets the requirements of the test and is
not considered to have a cytotoxic effect.
Irritation	10993-10	The test article sites did not show a
significantly greater biological reaction
than the sites injected with the control
article.	Based on the criteria of the protocol, the test
article meets the requirements of the ISO
10993-10 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 | | Compare
to
Standard | Compare
to
Predicate
Device |
|---|------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------|
| 1 | Sensitivity to
ambient light | ISO 4049: 2009
5.2.7 Sensitivity
to ambient light | Remain
physically
homogeneous. | G-Fix: Clear
Lot No.
1103011G
Conformed | GRADIA DIRECT
Flo (UNIFIL
FLOW): A1
Lot No. 1111211
Conformed | | |
| 2 | Depth of cure | ISO 4049: 2009
5.2.8 Depth of
cure | Not less than
1.5 mm | 5.6 mm
5.6 mm
5.7 mm
5.7 mm
5.7 mm
5.7(0.1) mm | 3.0 mm
3.0 mm
2.9 mm
3.0 mm
3.0 mm
3.0(0.0) mm | Exceeds | Exceeds |
| 3 | Flexural
strength | ISO 4049: 2009
5.2.9 Flexural
strength | Greater than
80 MPa | 100 MPa
89 MPa
99 MPa
93 MPa
90 Mpa
94(5) MPa | 96 MPa
101 MPa
99 MPa
93 MPa
93 Mpa
96(3.2) MPa | Exceeds | Equal |
| 4 | Water
sorption | ISO 4049: 2009
5.2.10 Water
sorption and
solubility | Less than 40
µg/mm³ | 36.1 µg/mm³
33.9 µg/mm³
34.4 µg/mm³
33.5 µg/mm³
34.6 µg/mm³
35(0.9) µg/mm³ | 33.1 µg/mm³,
35.4 µg/mm³,
36.7 µg/mm³,
34.0 µg/mm³,
33.9 µg/mm³
35(1.3) µg/mm³ | Exceeds | Equal |
| 5 | Solubility | ISO 4049: 2009
5.2.10 Water
sorption and
solubility | Less than 7.5
µg/mm³ | 0.8 µg/mm³
0.4 µg/mm³
0.6µg/mm³
0.7µg/mm³
0.7µg/mm³
0.6(0.1) µg/mm³ | 0.5 µg/mm³
0.5 µg/mm³
0.4 µg/mm³
0.6 µg/mm³
0.7 µg/mm³
0.5(0.1)µg/mm³ | Exceeds | Equal |
| 6 | 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 |
| 7 | Adhesion to
tooth
structure
(Enamel) | ISO/TS 11405:
2003 5.2.5
Shear bond
strength | Greater than
5MPa | 31 MPa
29 MPa
28 MPa
30 MPa
27 Mpa
29(1) MPa | 34 MPa
31 MPa
29 MPa
28 MPa
32 MPa
31(2) MPa
*This result was
obtained by the
combination with
phosphoric acid | Equal | Equal |

6

	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*
Product
Classification	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 cavities

Restoration of root surface caries
Restorations in deciduous teeth
Filling tunnel shaped cavities
Sealing hypersensitive areas
Liner / base / filling in cavity undercuts
Sealant
Fixing mobile teeth
Additions to composite restorations | Different
Note: #8 of
Comparitive
Device is
same as
applicant. |
| Product
description | G-Fix is a visible-light-cured resin cement for fixing
splinting mobile teeth . G-Fix is used in
combination with phosphoric acid as a
pre-treatment agent of tooth surfaces. | GRADIA DIRECT Flo (UNIFIL FLOW) is a light cured
highly flowable composite filled in a dental syringe.
The material is available in 7 shades. | Both light cured
Polymer based
material |
| 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 of
new device are
contained in
predicate and
device includes
Phosphoric
monomer that is
common in this
device type |
| Instructions for use | 1. Preparations

Shade Selection
Preparation in case of tooth structure (apply
phosphoric acid to the bonding surfaces of teeth for
30 seconds)
Preparation in case of restoration
Placement of G-Fix
Light Curing
Finishing and Polishing | 1. Shade Selection
Cavity Preparation
Bonding treatment
Placement of GRADIA DIRECT Flo (UNIFIL Flo)
Light Curing
Finishing and Polishing | Different in that
the indications
are narrower
than the
predicate |
| | | | Page 4 |

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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.