1. Bonding of light cured composites and acid modified composites (compomers) to tooth structure.
Bonding of dual cured luting and core build up composites to tooth structure as long as these materials 2. are light cured.
1. Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing.
Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, 4. CAD/CAM hybrid resin crowns and composites.
1. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
Treatment of hypersensitive teeth. 6.

Device Description

G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquid bottle or unit dose.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the G-Premio BOND device, organized according to your requested points:

Note: The provided document is a 510(k) premarket notification summary. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a device's standalone performance or clinical trials as might be found in a full scientific publication. Therefore, some of your requested information, particularly regarding "study" details like sample sizes for training sets, adjudication methods, or MRMC studies, is not present in this regulatory submission. The "study" described here is primarily a bench test to show compliance with internal specifications and substantial equivalence, not a clinical trial.

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Property	Requirements	Reported Device Performance (Implied)
1. Appearance	Should be homogenous and free from foreign matters	Conforms (implied by "conforms to the required specifications")
2. Curing property	Should be cured and formed film	Conforms (implied by "conforms to the required specifications")
3. Bond strength to tooth structure	> 10 MPa for enamel > 10 MPa for dentin	Equivalent to predicate bond strengths in enamel and dentin bonding. Results met the >10MPa requirement.
4. Bond strength to metal	> 10 MPa for precious metal > 10 MPa for non-precious metal	> 10 MPa (implied by "equivalent to the predicate bond strengths")
5. Bond strength to ceramic and composite	> 10 MPa for porcelain > 10 MPa for composite > 10 MPa for zirconia	> 10 MPa (implied by "equivalent to the predicate bond strengths")
6. Application characteristics	Should be formed even and homogenous coat.	Conforms (implied by "conforms to the required specifications")
7. Sealing property of dentin tubules	Should be sealed dentin tubules when observed using SEM	Dentin tubules were sealed (supported by SEM images)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in the document for the bench tests.
Data Provenance: The document implies that the testing was conducted by GC America Inc. or its parent company (GC Corporation), likely in a laboratory setting. There is no information regarding the country of origin of data or if it was retrospective or prospective in a clinical sense. These are bench test results, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The acceptance criteria were established by the company (GC America Inc. specification AB-15-Q-301-631(1)), and the performance was measured against these internal specifications and compared to a predicate device. There is no indication of external experts establishing a "ground truth" for the test set in the conventional sense of a clinical study.

4. Adjudication method for the test set

This information is not applicable/not provided for these types of bench tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of results (e.g., imaging) by multiple readers, which is not the nature of the performance tests described here (e.g., bond strength, curing properties, appearance).

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

No, an MRMC comparative effectiveness study was not done. This device is a dental bonding agent, a physical product, not an AI-powered diagnostic or assistive tool. Therefore, this question is not applicable to the device described.

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

No, this question is not applicable. The device is a dental bonding agent, and there is no algorithm involved. The performance tests are for the physical properties of the bonding agent itself.

7. The type of ground truth used

For physical properties like bond strength, curing, appearance, pH, etc., the "ground truth" is defined by established scientific and engineering measurement standards and internal company specifications. For the sealing property of dentin tubules, the "ground truth" was visual confirmation via Scanning Electron Microscopy (SEM) images (implied to be assessed as "sealed").
For the purpose of the 510(k) submission, the ultimate "ground truth" for demonstrating substantial equivalence was showing that the device performed similarly to or better than the predicate device across key technical characteristics, and met its own predefined specifications.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device, as it is a physical product and not a machine learning model.

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

This information is not applicable/not provided. As above, there is no "training set" for this type of device.

Summary

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

April 20, 2015

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

Re: K143140

Trade/Device Name: G-Premio BOND Regulation Number: 21 CFR 872.3200 Regulation Name: Resin, tooth bonding agent Regulatory Class: II Product Code: KLE Dated: December 15, 2014 Received: January 20, 2015

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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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): K143140

Device Name: G-Premio BOND

Indications for Use:

1. Bonding of light cured composites and acid modified composites (compomers) to tooth structure.
Bonding of dual cured luting and core build up composites to tooth structure as long as these materials 2. are light cured.
1. Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing.
Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, 4. CAD/CAM hybrid resin crowns and composites.
1. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
Treatment of hypersensitive teeth. 6.

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)

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

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Fax:	(708) 926-9100

Date Prepared: October 30, 2014

2 Device Name:

510(k) Number:	K143140
Proprietary Name:	G-Premio BOND
Classification Name:	Resin tooth bonding agent
Device Classification:	Class II, 872.3200
Product Code:	KLE

Predicate Devices: 1.

Company	Device	510(k) No.	Date Cleared
GC America Inc.	G-ænial Bond	K082768	2008/10/21

2. Description of Device:

G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquid bottle or unit dose.

3. Indications for Use:

Bonding of light cured composites and acid modified composites (compomers) to tooth a. structure.
Bonding of dual cured luting and core build up composites to tooth structure as long as these b. materials are light cured.
Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal C. backing.
d. Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, CAD/CAM hybrid resin crowns and composites.
Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and e. full zirconia crowns.
Treatment of hypersensitive teeth. f.
1. Technological characteristics:

All the compounds found in the applicant device, G-Premio BOND, have already been used in the predicate devices. The bonding mechanism of the predicate device is applying it to tooth structure, then bonding chemically and mechanically by polymerization of uncured methacrylate ester monomers. The chemical composition of the subject device is such that it can also bond to tooth surfaces (like the predicate) as well as composites, hybrid ceramics, and metals.

న్. Substantial equivalence:
The subject and predicate devices contain the same compounds, have similar indications, and are both light cured.

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	Applicant device	Comparative device
Product category	Resin tooth bonding agent, Class II	Resin tooth bonding agent, Class II
Trade name	G-Premio BOND	G-ænial Bond
Manufacturer	GC Corporation	GC Corporation
Intended use	For bonding light-cured composite resin to tooth structure, hybrid ceramics, composites, ceramics (porcelain, lithium disilicate, zirconia and alumina) and metals (precious and non-precious metals) surfaces. For treatment of hypersensitive teeth.	For bonding light-cured composite resin to tooth structure.
Product description	G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquid bottle or unit dose.	G-aenial Bond is a one component, light-cured bonding agent that allows bonding light-cured composite resins to tooth structure.

The applicant device complies with all the requirements of Company specification AB-15-Q-301-631(1) (see table below).

	Property	Requirements
1	Appearance	Should be homogenous and free from foreignmatters
2	Curing property	Should be cured and formed film
3	Bond strength totooth structure	>10MPa for enamel>10MPa for dentin
4	Bond strength tometal	>10MPa for precious metal>10MPa for non-precious metal
5	Bond strength toceramic andcomposite	>10MPa for porcelain>10MPa for composite>10MPa for zirconia
6	Applicationcharacteristics	Should be formed even and homogenouscoat.
7	Sealing propertyof dentin tubules	Should be sealed dentin tubules whenobserved using SEM

6. Differences

The following differences may be noted between the predicate device and G-Premio BOND.

G-Premio BOND is available for bonding light-cured composite resin to composites, hybrid ● ceramics, ceramics and metals surfaces as well as tooth structure.
. G-Premio BOND is available for treatment of hypersensitive teeth.

The specifications that are important to determine substantial equivalency of a dental adhesive system are bond strengths associated to enamel and dentin (tooth structure). The bond strengths as noted above compare the predicate device (G-aenial Bond, K082768) to the subject device. In both enamel and dentin bonding, the results were equivalent.

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In addition, bond strength of subject device to other substrates was equivalent to the predicate bond strengths to enamel and dentin. SEM images of sealed bovine dentin tubules also support indications for treatment of hypersensitive teeth.

Therefore, the subject device has been shown to be substantially equivalent to the predicate device.

7. Performance Bench Tests

It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:

· Appearance
· Curing property
· Application characteristics
Color
pH
Filler loading
· Refraction index

8. Packaging

G-Premio BOND Bottle:
5 mL liquid (1), disposable dispensing dish (20), disposable applicator (50) .
G-Premio BOND Unit Dose:
0.1mL liquid (50), disposable applicator (50) .
1. Shelf Life Evaluation and Storage Conditions:
- Shelf Life 2 years
- Recommended for optimal performance, store in a cool and dark place. 1-25°C (33.8 77.0°F)

10. Conclusion

Based on similarities in intended use, mode of action, chemical composition, and performance testing, G-Premio Bond is substantially equivalent to the selected predicate (K082768).

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.