GC Fuji Direct

K172382 · GC America, Inc. · EMA · Apr 2, 2018 · Dental

Device Facts

• Record ID: K172382
• Device Name: GC Fuji Direct
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Apr 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Class III and V restorations 2. Restoration of primary teeth 3. Core build-up 4. Cases where radiopacity is required 5. Base material for Class I and Class II cavities using a sandwich laminate technique.

Device Story

GC Fuji Direct is a light-cured, resin-modified glass ionomer cement; supplied as two pastes (A and B) in a Paste Pak Cartridge. Dispensed via Paste Pak Dispenser II; mixed either by hand or automixed using a mixing tip. Applied directly to prepared dental cavities by a dentist. Sets via dual mechanism: acid-base reaction (fluoroalumino-silicate glass and polyacrylic acid) and polymerization of methacrylate monomers. Used for Class III/V restorations, primary teeth, core build-ups, and as a base/liner. Radiopaque. Benefits include restorative functionality and structural support for dental cavities. Clinical decision-making is supported by the material's physical properties and radiopacity.

Clinical Evidence

No clinical testing performed. Evidence consists of bench testing confirming compliance with ISO 9917-2:2010 (resin-modified cements) and biocompatibility testing per ISO 10993-1:2009, including L929 MEM Elution (cytotoxicity), Kligman Maximization (sensitization), and intracutaneous injection (irritation). Bench performance metrics met requirements for flexural strength (>25 MPa), radiopacity, and color stability.

Technological Characteristics

Resin-modified glass ionomer cement. Materials: fluoroalumino-silicate glass, polyacrylic acid, methacrylate monomers. Setting: acid-base reaction and light-cured polymerization. Form factor: two-paste cartridge system. Connectivity: none. Sterilization: not specified. Standards: ISO 9917-2:2010, ISO 10993-1:2009.

Indications for Use

Indicated for Class III and V restorations, restoration of primary teeth, core build-up, cases requiring radiopacity, and as a base material for Class I and II cavities using a sandwich laminate technique.

Regulatory Classification

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. 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.

Predicate Devices

• GC FUJI FILLING LC (K051427)

Reference Devices

• GC Fuji II LC Capsule (K993973)
• GC FUJICEM 2 (K001730)
• GC Kalore (K082434)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA text is in a blue sans-serif font.

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

Re: K172382

Trade/Device Name: GC Fuji Direct Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, EBF Dated: February 27, 2018 Received: February 28, 2018

## Dear Mark 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.

April 2, 2018

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mary S. Runner -S

Tina Kiang, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K172382

Device Name GC Fuji Direct

Indications for Use (Describe)

- 1. Class III and V restorations
- 2. Restoration of primary teeth

3. Core build-up

- 4. Cases where radiopacity is required
5. Base material for Class I and Class II cavities using a sandwich laminate technique.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color and appear to be slightly italicized. There are single quotation marks before and after the letters. The background is white.

GC AMERICA INC

3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL [phone]
FAX [phone]
www.gcamerica.com

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

| | Contact Person: | Mark Heiss, D.D.S |
|----|------------------------|--------------------|
| | Phone: | [phone] |
| | Alternate Contact: | Lori Rietman |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Date Prepared: | March 26, 2018 |
| 2. | Device Name: | |
| | Proprietary Name: | GC Fuji Direct |
| | Classification Name: | Dental Cement |
| | Device Classification: | Class II, 872.3275 |
| | Product Code: | EMA |

- 3. Predicate Devices:

| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|-----------------------|-----------------|------------|---------|-----------|---------------|
| GC FUJI FILLING LC | GC America Inc. | K051427 | EMA | Primary | 08/22/2005 |
| GC Fuji II LC Capsule | GC America Inc. | K993973 | EMA | Reference | 01/11/2000 |
| GC FUJICEM 2 | GC America Inc. | K001730 | EMA | Reference | 07/17/2000 |
| GC Kalore | GC America Inc. | K082434 | EBF | Reference | 11/14/2008 |

#### 4. Description of Device:

GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.

GC Fuji Direct Package:

- Paste Pak Cartridge (14.9 g / 7.2 mL) (1) -
- -GC Fuji Direct Mixing Tip (20)
- Paste Pak Dispenser II (1) -

Shades available:

A1, A2, A3

Shelf Life and Storage Conditions:

- Shelf Life 2 years -
- -Recommended for optimal performance, store in a cool and dark place. 4-25℃ (39.2 - 77.0ºF)

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- న. Indications for Use:
- 1. Class III and V restorations
- 2. Restoration of primary teeth
- 3. Core Build-up
- 4. Cases where radiopacity is required

5 Base material for Class 1 and Class II cavities using a sandwich laminate technique

- 6. Performance Bench Tests:
It is confirmed that the device conforms to the required specifications of ISO 9917-2:2010.

- 7. Non Clinical Performance Testing:
A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

## Cytotoxicity (L929 MEM Elution Test)

Based on the criteria of the protocol of ISO 10993-5

## Sensitivitv (Kligman Maximization Test)

Based on the criteria of the protocol of ISO 10993-10

## Irritation (Intracutaneous Injection Test)

Based on the criteria of the protocol of ISO 10993-10

GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement and does come in contact with body tissues (tooth - enamel, dentin) for more than 24 hours.

In conclusion, biocompatibility of GC Fuji Direct is acceptable device from the biological evaluation result.

It is confirmed that the device conforms to the required specifications of ISO 9917-2: 2010 (Dentistry -Water-based cements -Part2: Resin-modified cements) and company standard is suitable for its intended use. Performance testing includes:

| Property | Requirements |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | *No visible sign of extraneous matter<br>*Free of any gelation |
| Working time | The indenter shall make a complete circular indentation. |
| Setting time | The indenter shall fail to make a complete circular indentation. |
| Flexural strength | More than 25 MPa |
| Radiopacity | More than equivalent thickness of aluminum |
| Shade and color stability | *Shade: Shall match with the manufacture's nominated shade guide<br>*Color stability: No significant change from the reference specimen |

#### 8. Clinical Performance Testing

No clinical testing has been performed on this device.

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| Table 5.1 | | | | | |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Applicant device | Primary Device | Reference Device | Reference Device | Reference Device |
| Trade name | GC Fuji Direct<br>K172382 | GC FUJI FILLING LC<br>K051427 | GC Fuji II LC Capsule<br>K993973 | GC FujiCEM 2<br>K001730 | GC Kalore<br>K082434 |
| Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation | GC Corporation |
| Product<br>category | Resin-modified glass<br>ionomer cement | Resin-modified glass<br>ionomer cement | Resin-modified glass ionomer<br>cement | Radiopaque reinforced<br>glass ionomer Luting<br>cement | Light-cured composite<br>restorative |
| Paste/Paste<br>ratio<br>Or<br>Powder/Liquid<br>ratio | Paste A / Paste B = 1.6 / 1.0<br>(w/w) | Paste A / Paste B = 3.3 / 1.0<br>(w/w) | Powder / Liquid = 3.3 / 1.0<br>(w/w) | Paste A / Paste B = 2.0 / 1.0<br>(w/w) | (1-paste) |
| Indications for<br>Use | 1. Class III and V restorations<br>2. Restoration of primary teeth<br>3. Core Build-up<br>4. Cases where radiopacity is<br>required<br>5 Base material for Class 1<br>and Class II cavities using a<br>sandwich laminate technique | 1. Class III and V<br>restorations, particularly for<br>cervical erosions and root<br>surface caries<br>2. Restoration of primary<br>teeth<br>3. Core build up<br>4. Cases where radiopacity is<br>required<br>5. As a base or a liner | 1. Class III and V restoration;<br>particularly areas<br>of cervical erosion,<br>abfraction lesions and<br>root surface caries<br>2. Restoration of primary teeth<br>3. As a base of liner<br>4. Core build-ups/block-outs<br>(particularly of vital teeth)<br>5. Cases in which a<br>radiopaque restoration is<br>required | 1. Cementation of<br>metal-based inlays, onlays,<br>crowns and bridges<br>2. Cementation of resin<br>inlays, onlays, crowns and<br>bridges<br>3. Cementation of all<br>ceramic inlays<br>4. Cementation of high<br>strength (zirconia based) all<br>ceramic crowns and bridges<br>5. Cementation of metal,<br>ceramic and fiber posts | 1. Direct restorative for<br>Class III, IV, V cavities.<br>2. Direct restorative for<br>wedge-shaped defects<br>and root surface<br>cavities.<br>3. Direct restorative for<br>veneers and diastema<br>closure.<br>4. Direct restorative for<br>Class I and II cavities. |
| Product<br>description | The device consists of 2<br>pastes filled in cartridges.<br>Paste A and B are<br>automixed with an automix<br>tip and directly applied to the<br>prepared cavity.<br>The bioactive material sets<br>by acid-base reaction of<br>fluoroalumino-silicate glass<br>and Polyacrylic acid, and<br>polymerization of<br>methacrylate monomers. | The device consists of 2<br>pastes filled in cartridges.<br>Paste A and B are mixed and<br>directly applied to the<br>prepared cavity.<br>The material sets by<br>acid-base reaction of<br>fluoroalumino-silicate glass<br>and Polyacrylic acid, and<br>polymerization of<br>methacrylate monomers. | The device consists of powder<br>and liquid filled in a capsule.<br>Powder & liquid are mixed with<br>electric capsule mixers. The<br>mixed material is directly<br>applied to a prepared cavity<br>using a capsule applier.<br>The material sets by acid-base<br>reaction of<br>fluoroalumino-silicate glass<br>and Polyacrylic acid, and<br>polymerization of<br>methacrylate monomers. | The device consists of 2<br>pastes filled in a Paste Pak<br>Cartridge. The material is<br>dispensed with GC Paste<br>Pak Dispenser and<br>hand-mixed. Optionally GC<br>FujiCEM Mixing Tip is<br>available for automixing<br>while pastes dispensation. | The device is a<br>light-cured micro-filled<br>radiopaque composite<br>resin for the restoration<br>of both anterior and<br>posterior teeth. The<br>device consists of two<br>delivery systems,<br>Unitip and Syringes.<br>The system is<br>available in a variety of<br>shades. |
| Table 5.1 (Continued) | | | | | |
| Instruction for<br>use | 1. Tooth preparation<br>2. Mix of 2 pastes<br>3. Application to cavity<br>4. Finishing | 1. Tooth preparation<br>2. Mix of 2 pastes<br>3. Application to cavity<br>4. Finishing | 1. Tooth preparation<br>2. Mix of powder and liquid<br>3. Application to cavity<br>4. Finishing | 1. Tooth preparation<br>2. Restoration<br>preparation<br>3. Mix of 2 pastes<br>4. Cementation | 1. Tooth Preparation<br>2. Bonding Treatment<br>3. Placement of GC KALORE<br>4. Contouring before Light Curing<br>6. Light Curing<br>7. Finishing and Polishing |
| Light curing<br>specification | Light cure using a light curing<br>unit.<br>10 sec. (High Power LED Light)<br>(>1200mW/cm2)<br>20 sec. (Halogen/LED) (700<br>mW/cm2) | Light cure the material with a<br>visible light curing device.<br>In the case of G-Light,<br>light-cure for 20 seconds. | Light-cure for 20 seconds<br>using a suitable visible light<br>curing device (470nm<br>wavelength) | | Light cure GC KALORE using<br>a light curing unit.<br>In the case of High power<br>LED (more than<br>1200mW/cm2) light-cure for<br>10 seconds.<br>In the case of Halogen / LED<br>(700mW/cm2) light-cure for<br>20 seconds. |
| Technological<br>Characteristics<br>and Mode of<br>action | The device is set by acid-base<br>reaction and polymerization<br>after mixing 2 pastes.<br>Acid-base reaction occurs<br>Fluoroalumino-silicate glass in<br>Paste A!and Polyacrylic acid in<br>Paste B. | The device is set by acid-base<br>reaction and polymerization<br>after mixing 2 pastes.<br>Acid-base reaction occurs<br>Fluoroalumino-silicate glass in<br>Paste A!and Polyacrylic acid in<br>Paste B. | The device is set by<br>acid-base reaction and<br>polymerization after mixing 2<br>pastes.<br>Acid-base reaction occurs<br>Fluoroalumino-silicate glass<br>in Paste A! and Polyacrylic<br>acid in Paste B.<br>Polymerization of<br>methacrylate monomers is<br>through dual cure. | The device is set by<br>acid-base reaction and<br>polymerization after mixing<br>2 pastes.<br>Acid-base reaction occurs<br>Fluoro-alumino-silicate<br>glass in Paste A! and<br>Polyacrylic acid in Paste B.<br>Polymerization of<br>methacrylate monomers is<br>through chemical cure. | The device consists of<br>several kinds of monomers to<br>be polymerized, and filler<br>elements.<br>The device is set by<br>polymerization.<br>Polymerization of<br>methacrylate monomers is<br>through light cure. |

# Table 5.1

Page 5.3 of 5.5

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#### 9. Substantial equivalence:

The applicant device complies with all the requirements of ISO 9917-2: 2010 (Dentistry - Water-based cements -Part2: Resin-modified cements).

The curing mechanism of the applicant device and predicate device-are substantially equivalent in principle. Therefore, the applicant device and predicate device are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

## 10. Differences

The following differences may be noted between GC Fuji Direct and the predicate device.

- There are slight differences in indications for use, however, differences are verbiage. The same applies to reference device, GC Fuji II LC Capsule.
- The applicant device is automixed with an automix tip while the predicate device is hand mixed. -

## 11. Conclusion

Based on similarities in intended use, mode of action, chemical composition, and performance testing. GC Fuji Direct is substantially equivalent to the predicate device.