everX Flow

K192260 · GC America, Inc. · EBF · Nov 22, 2019 · Dental

Device Facts

• Record ID: K192260
• Device Name: everX Flow
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

everX Flow is a reinforcing dentin replacement material suitable for: 1. All direct composite restorations including large posterior cavities. 2. Deep cavities and endo-treated teeth. 3. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended. 4. Core build-up

Device Story

everX Flow is a light-cured, short-fiber-reinforced composite resin used as a dentin replacement material in dental clinics. It is supplied in a syringe and applied by dental professionals to restore posterior and anterior teeth. The material functions as a reinforcing base for direct composite restorations, deep cavities, endo-treated teeth, and core build-ups. It polymerizes via a photo-initiator system upon exposure to a dental curing light. By providing structural reinforcement, it benefits patients by supporting restorations in compromised tooth structures, such as those with missing cusps or significant decay. The clinician uses the material to fill the cavity preparation before placing a final composite layer, improving the durability and integrity of the restoration.

Clinical Evidence

No clinical testing performed. Substantial equivalence is supported by bench testing confirming compliance with ISO 4049:2009 standards for sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, color stability, and radiopacity. Biocompatibility was assessed per ISO 10993-1:2009 and ISO 10993-5, confirming the material is non-cytotoxic.

Technological Characteristics

Light-cured, short-fiber-reinforced composite resin. Materials: methacrylate ester monomers. Curing: photo-initiator system. Form factor: syringe-dispensed. Standards: ISO 4049:2009 (polymer-based restorative materials), ISO 10993-1:2009 (biocompatibility).

Indications for Use

Indicated for patients requiring direct composite restorations, including large posterior cavities, deep cavities, endo-treated teeth, cavities with missing cusps, post-amalgam removal, or core build-up.

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

• everX Posterior (K153127)

Reference Devices

• Gradia Core (K082171)
• G-aenial Flo X (K133182)

Submission Summary (Full Text)

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November 22, 2019

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

Re: K192260

Trade/Device Name: everX Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 20, 2019 Received: August 21, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

| 510(k) Number (if known) |
|--------------------------|
|--------------------------|

| Device Name | everX Flow |
|--------------------------------|------------|
| Indications for Use (Describe) | |

everX Flow is a reinforcing dentin replacement material suitable for:

- 1. All direct composite restorations including large posterior cavities.
- 2. Deep cavities and endo-treated teeth.
- 3. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
- 4. Core build-up

| 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) |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### 510(k) Summary - K192260

| 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: | October 28, 2019 |
| 2. Device Name: | |
| Proprietary Name: | everX Flow |
| Classification Name: | Tooth shade resin material |
| Device Classification: | Class II, 872.3690 |

- 3. Predicate Devices:
Product Code:

| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|-----------------|-----------------|------------|---------|-----------|---------------|
| everX Posterior | GC America Inc. | K153127 | EBF | Primary | 05/20/2016 |
| Gradia Core | GC America Inc. | K082171 | EBF | Reference | 10/30/2008 |
| G-aenial Flo X | GC America Inc. | K133182 | EBF | Reference | 4/9/2014 |

#### 4. Description of Device:

everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.

### 5. Indications for Use:

- everX Flow is a reinforcing dentin replacement material suitable for: ● All direct composite restorations including large posterior cavities.
EBF

- . Deep cavities and endo-treated teeth.
- . Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
- . Core build-up

#### 6. Packaging

everX Flo Package:

- i Syringe (3.7 g / 2 mL) QTY: 1
- Dispensing Tip III QTY: 20 -
- Light protective cap QTY: 1 i
- 7. Shades

Shades available: Bulk Shade, Dentin Shade

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- 8. Shelf Life and Storage Conditions:
- Shelf Life 3 years ।
- Recommended for optimal performance, store in a cool and dark place (4-25°C / 39.2-77.0°F) away from high temperatures i or direct sunlight.

#### Performance Bench Tests 9.

It is confirmed that the device conforms to the required specifications 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
- · Radiopacity

The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials) (see table below).

| | Property | Requirements |
|---|------------------------------------------------------|-------------------------------------------------|
| 1 | Sensitivity to ambient light | Remain physically homogeneous |
| 2 | Depth of cure | Opaque shade: > 1.0 mm<br>Other shade: > 1.5 mm |
| 3 | Flexural strength | > 80 MPa |
| 4 | Water sorption | < 40 µg/mm³ |
| 5 | Solubility | < 7.5 µg/mm³ |
| 6 | Color stability after irradiation and water sorption | No more than slight change in color |
| 7 | Radiopacity | Greater than the same thickness of aluminum |

### 10. 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.

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.

- 11. Clinical Performance Testing
No clinical testing has been performed on this device.

# 12. Comparison of Technology

The main difference between the applicant device and primary predicate device is the flow. The indications for use were similar as well. The formula was modified without issue associated with safety and efficacy. In addition, biocompatibility studies were successfully completed. Mechanism for curing and polymerization did not change. Also, depth of cure was similar.

- 2

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| | Applicant device | Primary Predicate Device | Reference Predicate Device | Reference Device |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>category | Tooth shade resin material, Class II | Tooth shade resin material, Class II | Tooth shade resin material, Class II | Tooth shade resin material, Class II |
| Trade name | everX Flow | everX Posterior | Gradia Core | G-AENIAL FLO X (HTFX-222) |
| 510(k) | Pending | K153127 | K082171 | K133182 |
| Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation |
| Indications for<br>use | everX Flow is a reinforcing dentin<br>replacement material suitable for:<br>1. All direct composite restorations<br>including large posterior cavities.<br>2. Deep cavities and endo-treated teeth.<br>3. Cavities with missing cusps or after<br>amalgam removal and cavities where<br>inlays and onlays would also be<br>recommended.<br>4. Core build-up | everX Posterior is suitable for use as the<br>reinforcing material for direct composite<br>restorations, especially in large posterior<br>cavities, for example:<br>1. Cavities including 3 surfaces or more.<br>2. Cavities with missing cusps.<br>3. Deep cavities (including class I, II and<br>endodontically treated teeth).<br>4. Cavities after amalgam replacement.<br>5. Cavities where onlays & inlays would also<br>be indicated. | GRADIA CORE is intended to be used for<br>restoration, core build-up and post<br>cementation. | 1. Liner or base<br>2. Blocking out undercuts<br>3. Repair of (in) direct aesthetic<br>restorations, temporary crown &<br>bridge, defect margins when margins<br>are in enamel<br>4. Sealing hypersensitive areas<br>5. Fissure sealant<br>6. Direct restorative for small Class II,<br>III, IV, I and V cavities |
| Product<br>description | everX Flow is a light cured, short-fiber-<br>reinforced composite for dentin<br>replacement for the restoration of<br>posterior and anterior teeth. EverX Flow<br>is filled in a syringe. The material is<br>available in two shades, Bulk shade and<br>Dentin shade. | everX Posterior is a fiber-reinforced<br>composite resin filled in a unitip. The device<br>is a universal type. The material is available<br>in one universal shade. The device is<br>suitable for use as the reinforcing material<br>for direct composite restorations, especially<br>in large posterior cavities. | GRADIA CORE consists of the two<br>articles, GRADIA CORE cartridge and<br>GRADIA CORE self-etching bond.<br>GRADIA CORE cartridge is a two-paste<br>(base and catalyst) type, dual-cured<br>composite resin filled in double syringe to<br>provide auto-mixing system. GRADIA<br>CORE cartridge paste comprises four<br>shades, Universal, Dentin, White and Blue.<br>GRADIA CORE self-etching bond is a two-<br>liquid (liquid A and liquid B), dual-cured<br>self-etching bonding agent. | G-AENIAL FLO X (HTFX-222) is a light<br>cured nano-filled radiopaque composite<br>resin filled in a syringe. The device is<br>used for the restorations of both<br>anterior and posterior teeth |
| Technological<br>Characteristics<br>and Mode of<br>action | The curing mechanism is polymerization<br>of uncured methacrylate ester<br>monomers. This reaction is caused by<br>photo initiator system. | The curing mechanism of the predicate is<br>polymerization of uncured methacrylate<br>ester monomers. This reaction is caused by<br>photo initiator system. | The curing mechanism of the predicate is<br>polymerization of uncured methacrylate<br>ester monomers. This reaction is caused<br>by photo initiator system and is assisted by<br>chemical curing. | The curing mechanism of the predicate<br>devices is polymerization of uncured<br>methacrylate ester monomers. This<br>reaction is caused by photo initiator<br>system. |

# 13. Conclusion

Based upon similarities in technology and indical performance testing, we believe that ever X Flow is substantially equivalent to the predicate devices.