everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.

Device Description

everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the everX Posterior dental device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and that the "testing results indicate that the device conforms to the required specifications."

Based on the information provided, the key performance criteria for everX Posterior are:

Acceptance Criteria (from ISO 4049:2009)	Reported Device Performance (as stated in the document)
Sensitivity to ambient light	Conforms to required specifications
Depth of cure	Conforms to required specifications
Flexural strength	Conforms to required specifications
Water sorption	Conforms to required specifications
Solubility	Conforms to required specifications
Color stability after irradiation and water sorption	Conforms to required specifications

For biocompatibility, the criteria are defined by ISO 10993-1, with specific tests:

Acceptance Criteria (from ISO 10993-1)	Reported Device Performance (as stated in the document)
Cytotoxicity (ISO 10993-5)	Testing performed
Sensitization (ISO 10993-10)	Testing performed
Irritation (ISO 10993-10)	Testing performed
The document states these tests were performed and implies successful completion to ensure biocompatibility for the intended use.

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

The document does not specify the sample size used for the bench tests.
The data provenance is not explicitly stated in terms of country of origin, but it is from non-clinical laboratory bench testing. The study is retrospective in the sense that the results are being presented as completed tests rather than a prospective study setup.

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

This information is not applicable as the studies described are non-clinical bench tests (physical and chemical properties, biocompatibility) of a material, not diagnostic or clinical interpretation studies requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Bench tests follow standardized procedures, and the results are typically measured objectively by instruments or established laboratory methods, not through expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is a dental restorative material, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its evaluation.

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

This information is not applicable. The device is a physical dental material, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the physical and chemical properties (e.g., flexural strength, depth of cure, water sorption, solubility, color stability), the "ground truth" is established by the defined specifications and test methods outlined in ISO 4049:2009. The device's performance is measured against these objective standards.
For biocompatibility, the "ground truth" is established by the scientific consensus and methodologies defined in ISO 10993-1, ISO 10993-5, and ISO 10993-10 for evaluating biological responses to medical devices.

8. The Sample Size for the Training Set

This information is not applicable. The testing described is for a physical material's properties and biocompatibility, not for training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design featuring a series of overlapping human profiles, creating a sense of unity and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2016

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

Re: K153127

Trade/Device Name: everX Posterior Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 21, 2016 Received: April 22, 2016

Dear Dr. 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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Page 2 - Mark Heiss, D.D.S.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.

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: K153127

Device Name: everX Posterior

Indications for Use:

everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page 4.1 of 4.1

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Image /page/3/Picture/1 description: The image shows the text "'GC'" in a stylized, sans-serif font. The text is a teal color, and the letters are slightly italicized. The apostrophes are also teal and are placed at the beginning and end of the text.

GC AMERICA INC.

3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 926-9100
www.gcamerica.com

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) 926-9100

Date Prepared: April 21, 2016

1. Device Name:

510(k) Number:	K153127
Proprietary Name:	everX Posterior
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 872.3690
Product Code:	EBF

1. Predicate Devices:

	Product	Applicant	Submission	Procode
Primary	Build-It Total Core	Sybron Dental Specialties,Inc.	K102703	EBF
Reference	G-aenial Sculpt(MFP-051)	GC America Inc.	K123631	EBF

4. Description of Device:

everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.

న్. Indications for Use:
everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.

Technological characteristics: 6.

The applicant device is composed of randomly oriented short E-glass and inorganic particulate fillers in combination with a semi-interpenetrating polymer network matrix that consists of bisphenol A glysidyl methacrylate, triethyleneglycol dimethacrylate and polymethylmethacrylate. The glass fibers are pre-impregnated into the composite resin and are 0.8 mm average length.

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	Applicant device	Predicate Device	Reference Device
Trade name	everX Posterior	Build-It Total Core	G-ænial Sculpt (MFP-051)
Manufacturer	GC Corporation	Sybron Dental Specialties	GC Corporation
Indicationsfor Use	everX Posterior is indicated foruse as a fiber reinforcedcomposite for the restoration ofprepared carious teeth, includinglarge posterior cavities with lossof dentin.	Build-it Total Core is indicated foruse as1. Core build up material on vitaland non-vital teeth2. Sealing root canal openings,3. Cavity floor liner,4. Post cementation,5. Restorative material6. Dentin replacement material.	1. Direct restorative for class I,II, III, IV, V cavities.2. Direct restorative forwedge-shaped defects and rootsurface cavities.3. Direct restorative for veneersand diastema closure.
Productdescription	everX Posterior is afiber-reinforced, universal shadecomposite resin paste filled in aunitip suitable as a reinforcingmaterial for direct compositerestorations, especially in largeposterior cavities.Physical properties are within theacceptable range for flexuralstrength, depth of cure, watersorption, solubility in accordancewith ISO 4049:2009 Dentistry -Polymer based restorative materials	Build-it Total Core is a twocomponent, catalyst and base, fiberreinforced, self-adhesive compositethat contains fluoride, and isavailable in esthetic and contrastshadesPhysical properties tested includeflexural strength, compressivestrength, water solubility, waterabsorption	G-aenial Sculpt is a light curednano-filled radiopaquecomposite resin filled in asyringe and unitip andavailable in several shades.The device is used for therestorations of both anteriorand posterior teeth.Physical properties testedIn accordance with ISO4049:2009 Dentistry - Polymerbased restorative materials
Mode of action	The paste material with glassfibers contains aphoto initiator to allow forpolymerization through lightcuring resulting in a solidmaterial for dentalrestorations.	The two component paste materialuses dual cure to become asolid material for dentalrestorations	G-aenial Sculpt is a pastecomposite reinforced by adispersion of filler particlesbonded to the resin matrix with aphoto initiator to allow forcuring/conversion. The end resultis a conversion from a paste to asolid material for dentalrestorations.

7. Non clinical performance testing

Bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and the testing results indicate that the device conforms to the required specifications for sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, and color stability after irradiation and water sorption and is therefore suitable for the intended use.

8. Biocompatibility

Biocompatibility assessment was based upon ISO 10993-1 and testing included cytotoxicity in accordance with ISO 10993-5, and sensitization and irritation in accordance with ISO 10993-10.

Substantial equivalence: 9.

everX Posterior is similar to the primary predicate (K102703) Build-It Total Core in that both are fiber

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reinforced composite material used for dental restorations; both devices make use of pre-impregnated glass fibers to provide support to the composite mix for their intended use: both devices are indicated for use in large cavities with loss of dentin including posterior teeth, tooth core structure replacement or build up. The predicate device is not indicated for use as a root canal sealer and cavity liner because it is not self-adhesive meaning like the predicate K102703. A technologic difference between the applicant device and primary predicate device is that the applicant device is a light cured paste with a photo initiator, while the predicate device K102703 is a dual cure, two paste system of catalyst and base, and that contains fluoride. In principle, the curing mechanism of the applicant and predicate devices is substantially equivalent in principle as they both undergo polymerization to become a solid material adapted to a cavitation in a tooth to become a dental restoration.

everX Posterior and the reference predicate G-aenial Sculpt (K123631) are both light cured composite resins intended to be used as dental restorative materials: the device formulations are identical for all components, except that the applicant device also includes glass fibers and polymethylmethacrylate. everX Posterior is available only in universal shade whereas both of the predicates are available in a range of shades.

All three devices have been tested for physical properties including flexural strength, water sorption, depth of cure. The results of testing the physical properties of the applicant device in accordance with the FDA recognized standard for polymer based restorative materials used in dentistry, demonstrate that the applicant device is similar to the predicate devices in function and intended use.

10. Conclusion

Given the similarities in intended use, mode of action, and chemical composition, and in consideration of the results of non-clinical performance testing and biocompatibility testing, everX Posterior is substantially equivalent to the predicate and reference devices.

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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.