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

Device Description

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.

AI/ML Overview

The provided document pertains to a 510(k) premarket notification for a dental device named "everX Flow," a tooth shade resin material. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing (performance testing) and biocompatibility assessment, rather than clinical performance testing involving human subjects or AI-assisted diagnostic studies.

Therefore, many of the requested details regarding acceptance criteria, study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone AI performance), and ground truth establishment for a diagnostic AI device are not applicable to this submission. This is a material science and dental product regulatory submission, not a medical AI/software as a medical device (SaMD) submission.

However, I can extract and present the acceptance criteria and performance data that are relevant to this type of device, which is primarily laboratory bench testing.

Acceptance Criteria and Reported Device Performance for everX Flow (Dental Resin Material)

This device, "everX Flow," is a dental restorative material, not an AI or diagnostic device. Therefore, the "acceptance criteria" refer to the physical, chemical, and biological properties of the material itself, as tested in a laboratory setting according to international standards (ISO 4049:2009 and ISO 10993-1:2009 for biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Requirements per ISO 4049:2009)	Reported Device Performance (Compliance)
Sensitivity to ambient light	Remain physically homogeneous	Conforms
Depth of cure (Opaque shade)	> 1.0 mm	Conforms (similar to predicate)
Depth of cure (Other shade)	> 1.5 mm	Conforms (similar to predicate)
Flexural strength	> 80 MPa	Conforms
Water sorption	< 40 µg/mm³	Conforms
Solubility	< 7.5 µg/mm³	Conforms
Color stability after irradiation and water sorption	No more than slight change in color	Conforms
Radiopacity	Greater than the same thickness of aluminum	Conforms
Biocompatibility (Cytotoxicity)	Not considered to have a cytotoxic effect	Meets requirements

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance bench tests and biocompatibility assessments.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify exact sample sizes for each bench test (e.g., how many specimens were tested for flexural strength). It broadly states that "Performance testing includes" a list of properties and that the device "complies with all the requirements of ISO 4049: 2009." ISO standards typically define the minimum number of samples for each test, and the claim of compliance implies these were followed.
Data Provenance: The tests were conducted internally by the manufacturer (GC Corporation) or a contracted lab. The data is prospective, generated specifically for this regulatory submission. The country of origin of the data is not explicitly stated but is implicitly Japan, as GC Corporation is the manufacturer.

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

Not Applicable. This is a material properties test, not a diagnostic study requiring expert human interpretation. The "ground truth" is defined by established international standards (ISO 4049:2009) and the results are quantifiable physical/chemical measurements.

4. Adjudication Method for the Test Set

Not Applicable. As this involves objective laboratory measurements against defined standards, there is no human interpretation or adjudication process required for the primary test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

Not Applicable. This is a dental material, not a diagnostic AI system or medical imaging device. No MRMC study was conducted. The relevant comparison in this submission is the "substantial equivalence" of the material's properties (composition, curing mechanism, performance characteristics) to existing predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This product is a physical dental material; it does not contain or rely on an algorithm or AI.

7. The type of ground truth used

Defined Standards and Objective Measurements: The "ground truth" for the performance tests is established by the specified requirements in ISO 4049:2009 for dental polymer-based restorative materials. The measurements (e.g., depth in mm, strength in MPa, mass change in µg/mm³) are objective and quantitative. For biocompatibility, the ground truth is established by the guidelines of ISO 10993-5 (in vitro cytotoxicity).

8. The sample size for the training set

Not Applicable. This product is a physical dental material, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no ground truth establishment for one. The development of the material itself would involve R&D and quality control processes, but not "ground truth establishment" in the AI/diagnostic sense.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
1. Deep cavities and endo-treated teeth.
1. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
1. 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)

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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:	(708) 926-3090
Alternate Contact:	Lori Rietman
Phone:	(708) 926-3092
Fax:	(708) 925-0373
Date Prepared:	October 28, 2019
2. Device Name:
Proprietary Name:	everX Flow
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 872.3690

1. 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:

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
1. Shades

Shades available: Bulk Shade, Dentin Shade

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1. 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 mmOther 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.

1. 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.

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	Applicant device	Primary Predicate Device	Reference Predicate Device	Reference Device
Productcategory	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 foruse	everX Flow is a reinforcing dentinreplacement material suitable for:1. All direct composite restorationsincluding large posterior cavities.2. Deep cavities and endo-treated teeth.3. Cavities with missing cusps or afteramalgam removal and cavities whereinlays and onlays would also berecommended.4. Core build-up	everX Posterior is suitable for use as thereinforcing material for direct compositerestorations, especially in large posteriorcavities, for example:1. Cavities including 3 surfaces or more.2. Cavities with missing cusps.3. Deep cavities (including class I, II andendodontically treated teeth).4. Cavities after amalgam replacement.5. Cavities where onlays & inlays would alsobe indicated.	GRADIA CORE is intended to be used forrestoration, core build-up and postcementation.	1. Liner or base2. Blocking out undercuts3. Repair of (in) direct aestheticrestorations, temporary crown &bridge, defect margins when marginsare in enamel4. Sealing hypersensitive areas5. Fissure sealant6. Direct restorative for small Class II,III, IV, I and V cavities
Productdescription	everX Flow is a light cured, short-fiber-reinforced composite for dentinreplacement for the restoration ofposterior and anterior teeth. EverX Flowis filled in a syringe. The material isavailable in two shades, Bulk shade andDentin shade.	everX Posterior is a fiber-reinforcedcomposite resin filled in a unitip. The deviceis a universal type. The material is availablein one universal shade. The device issuitable for use as the reinforcing materialfor direct composite restorations, especiallyin large posterior cavities.	GRADIA CORE consists of the twoarticles, GRADIA CORE cartridge andGRADIA CORE self-etching bond.GRADIA CORE cartridge is a two-paste(base and catalyst) type, dual-curedcomposite resin filled in double syringe toprovide auto-mixing system. GRADIACORE cartridge paste comprises fourshades, Universal, Dentin, White and Blue.GRADIA CORE self-etching bond is a two-liquid (liquid A and liquid B), dual-curedself-etching bonding agent.	G-AENIAL FLO X (HTFX-222) is a lightcured nano-filled radiopaque compositeresin filled in a syringe. The device isused for the restorations of bothanterior and posterior teeth
TechnologicalCharacteristicsand Mode ofaction	The curing mechanism is polymerizationof uncured methacrylate estermonomers. This reaction is caused byphoto initiator system.	The curing mechanism of the predicate ispolymerization of uncured methacrylateester monomers. This reaction is caused byphoto initiator system.	The curing mechanism of the predicate ispolymerization of uncured methacrylateester monomers. This reaction is causedby photo initiator system and is assisted bychemical curing.	The curing mechanism of the predicatedevices is polymerization of uncuredmethacrylate ester monomers. Thisreaction is caused by photo initiatorsystem.

13. Conclusion

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

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.