G-Fix

K151541 · GC America, Inc. · EBF · Oct 9, 2015 · Dental

Device Facts

• Record ID: K151541
• Device Name: G-Fix
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Splinting mobile teeth

Device Story

G-Fix is a light-cured resin cement used by dental professionals to splint mobile teeth. The device is applied to tooth surfaces following pre-treatment with phosphoric acid. It functions via a photo-initiator system that triggers the polymerization of methacrylate ester monomers when exposed to light. The material is supplied in dental composite dispensing syringes. By providing a stable bond to the enamel, the device stabilizes mobile teeth, potentially improving patient comfort and dental function. It is intended for clinical use by dentists.

Clinical Evidence

Bench testing only. The device was evaluated against ISO 4049:2009 and ISO/TS 11405:2003 standards. Testing included sensitivity to ambient light, depth of cure (5.7mm), flexural strength (94 MPa), water sorption (35 µg/mm³), solubility (0.6 µg/mm³), color stability, and shear bond strength to enamel (29 MPa). Biocompatibility was assessed per ISO 10993-1, 10993-5, and 10993-10, confirming no cytotoxicity, irritation, or significant sensitization.

Technological Characteristics

Light-cured resin cement composed of barium glass, UDMA, Bis-MEPP, phosphoric ester monomer, silicon dioxide, photo initiator, and pigments. Operates via photo-initiated polymerization of methacrylate ester monomers. Form factor is a 2.7g dental composite dispensing syringe. Complies with ISO 4049:2009 and ISO/TS 11405:2003. No software or electronic components.

Indications for Use

Indicated for splinting mobile teeth.

Regulatory Classification

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.

Predicate Devices

• GRADIA DIRECT Flo (UNIFIL FLOW) (K020342)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone]
FAX [phone]

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

| Contact Person: | Mark Heiss, D.D.S. |
|-----------------|--------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| 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:

1. 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

- 9. Shades
Clear and TC (Tooth Color)

- 10. 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)
- 11. 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 of<br>Kligman, this is a Grade I reaction and<br>the test article is classified as having<br>weak allergenic potential. | Based on the criteria of the protocol, a<br>Grade I sensitization rate is not considered<br>significant and the test article meets the<br>requirements of the ISO 10993-10<br>guidelines. |
| Cytotoxicity | 10993-5 | There was no biological reactivity of the<br>cells exposed to the test article extract.<br>The response obtained from the positive<br>and negative control article extracts<br>confirmed the suitability of the test<br>system. | Based on the criteria of the protocol and the<br>ISO 10993-5 guidelines, the test article<br>meets the requirements of the test and is<br>not considered to have a cytotoxic effect. |
| Irritation | 10993-10 | The test article sites did not show a<br>significantly greater biological reaction<br>than the sites injected with the control<br>article. | Based on the criteria of the protocol, the test<br>article meets the requirements of the ISO<br>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<br>to<br>Standard | Compare<br>to<br>Predicate<br>Device |
|---|------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------|
| 1 | Sensitivity to<br>ambient light | ISO 4049: 2009<br>5.2.7 Sensitivity<br>to ambient light | Remain<br>physically<br>homogeneous. | G-Fix: Clear<br>Lot No.<br>1103011G<br>Conformed | GRADIA DIRECT<br>Flo (UNIFIL<br>FLOW): A1<br>Lot No. 1111211<br>Conformed | | |
| 2 | Depth of cure | ISO 4049: 2009<br>5.2.8 Depth of<br>cure | Not less than<br>1.5 mm | 5.6 mm<br>5.6 mm<br>5.7 mm<br>5.7 mm<br>5.7 mm<br>5.7(0.1) mm | 3.0 mm<br>3.0 mm<br>2.9 mm<br>3.0 mm<br>3.0 mm<br>3.0(0.0) mm | Exceeds | Exceeds |
| 3 | Flexural<br>strength | ISO 4049: 2009<br>5.2.9 Flexural<br>strength | Greater than<br>80 MPa | 100 MPa<br>89 MPa<br>99 MPa<br>93 MPa<br>90 Mpa<br>94(5) MPa | 96 MPa<br>101 MPa<br>99 MPa<br>93 MPa<br>93 Mpa<br>96(3.2) MPa | Exceeds | Equal |
| 4 | Water<br>sorption | ISO 4049: 2009<br>5.2.10 Water<br>sorption and<br>solubility | Less than 40<br>µg/mm³ | 36.1 µg/mm³<br>33.9 µg/mm³<br>34.4 µg/mm³<br>33.5 µg/mm³<br>34.6 µg/mm³<br>35(0.9) µg/mm³ | 33.1 µg/mm³,<br>35.4 µg/mm³,<br>36.7 µg/mm³,<br>34.0 µg/mm³,<br>33.9 µg/mm³<br>35(1.3) µg/mm³ | Exceeds | Equal |
| 5 | Solubility | ISO 4049: 2009<br>5.2.10 Water<br>sorption and<br>solubility | Less than 7.5<br>µg/mm³ | 0.8 µg/mm³<br>0.4 µg/mm³<br>0.6µg/mm³<br>0.7µg/mm³<br>0.7µg/mm³<br>0.6(0.1) µg/mm³ | 0.5 µg/mm³<br>0.5 µg/mm³<br>0.4 µg/mm³<br>0.6 µg/mm³<br>0.7 µg/mm³<br>0.5(0.1)µg/mm³ | Exceeds | Equal |
| 6 | Color stability<br>after<br>irradiation<br>and water<br>sorption | ISO 4049: 2009<br>5.4 Color<br>stability after<br>irradiation and<br>water sorption | No more than<br>slight change<br>in color | Conformed | Conformed | Equal | Equal |
| 7 | Adhesion to<br>tooth<br>structure<br>(Enamel) | ISO/TS 11405:<br>2003 5.2.5<br>Shear bond<br>strength | Greater than<br>5MPa | 31 MPa<br>29 MPa<br>28 MPa<br>30 MPa<br>27 Mpa<br>29(1) MPa | 34 MPa<br>31 MPa<br>29 MPa<br>28 MPa<br>32 MPa<br>31(2) MPa<br>*This result was<br>obtained by the<br>combination with<br>phosphoric 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* |
| Product<br>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<br>2. Restoration of root surface caries<br>3. Restorations in deciduous teeth<br>4. Filling tunnel shaped cavities<br>5. Sealing hypersensitive areas<br>6. Liner / base / filling in cavity undercuts<br>7. Sealant<br>8. Fixing mobile teeth<br>9. Additions to composite restorations | Different<br>Note: #8 of<br>Comparitive<br>Device is<br>same as<br>applicant. |
| Product<br>description | G-Fix is a visible-light-cured resin cement for fixing<br>splinting mobile teeth . G-Fix is used in<br>combination with phosphoric acid as a<br>pre-treatment agent of tooth surfaces. | GRADIA DIRECT Flo (UNIFIL FLOW) is a light cured<br>highly flowable composite filled in a dental syringe.<br>The material is available in 7 shades. | Both light cured<br>Polymer based<br>material |
| Components | * Barium glass<br>* Urethane dimethacrylate (UDMA)<br>* Bisphenol A polyethoxy methacrylate<br>(Bis-MEPP)<br>* Phosphoric ester monomer<br>* Silicon dioxide<br>* Photo initiator<br>* Pigment | * Fluoro-alumino-silicate glass<br>* Urethane dimethacrylate (UDMA)<br>* Dimethacrylate<br>* Silicon dioxide<br>* Photo initiator<br>* Pigment | Components of<br>new device are<br>contained in<br>predicate and<br>device includes<br>Phosphoric<br>monomer that is<br>common in this<br>device type |
| Instructions for use | 1. Preparations<br>2. Shade Selection<br>3. Preparation in case of tooth structure (apply<br>phosphoric acid to the bonding surfaces of teeth for<br>30 seconds)<br>4. Preparation in case of restoration<br>5. Placement of G-Fix<br>6. Light Curing<br>7. Finishing and Polishing | 1. Shade Selection<br>2. Cavity Preparation<br>3. Bonding treatment<br>4. Placement of GRADIA DIRECT Flo (UNIFIL Flo)<br>5. Light Curing<br>6. Finishing and Polishing | Different in that<br>the indications<br>are narrower<br>than the<br>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.