Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)

Device Description

GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.

AI/ML Overview

The device in question is GC ACRYLIC PRIMER, a resin tooth bonding agent.

Here's a breakdown of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Requirements (Acceptance Criteria)	Reported Device Performance
Appearance	No contamination of foreign matter.	Conforms to specification.
Application characteristics (coating properties)	Equivalent to reference standard.	Conforms to specification.
Refractive index	1.398 ± 0.003	Conforms to specification.
Bond strength	> 10 MPa	Conforms to specification.
Biocompatibility	Not considered to have a cytotoxic effect (per ISO 10993-5 guidelines)	Meets requirements of the test.

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

The document does not specify a distinct "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI. The performance bench tests appear to be conducted on the device itself.

Sample Size for Test Set: Not explicitly stated for performance bench tests, but implied to be sufficient to demonstrate conformity to specifications.
Data Provenance: Not applicable in the context of a "test set" as typically understood for AI/clinical studies. The performance data is generated from laboratory bench testing of the device.

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

Not applicable. The performance testing involves laboratory measurements and assessments against predefined physical and chemical specifications, not expert-derived ground truth on clinical data.

4. Adjudication method for the test set

Not applicable. The performance testing involves objective measurements rather than 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

No MRMC comparative effectiveness study was conducted. This device is a dental material (primer) and not an AI-powered diagnostic tool.

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

Not applicable. This device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance criteria is based on:

Predefined physical and chemical specifications: For appearance, application characteristics, refractive index, and bond strength. These are objective laboratory measurements.
Biocompatibility standards: ISO 10993-5 guidelines for cytotoxicity.

8. The sample size for the training set

Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set.

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

Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set or associated ground truth establishment.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.

November 20, 2018

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

Re: K180917

Trade/Device Name: GC Acrylic Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 23, 2018 Received: August 24, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 0ate: 2018.11.20

forTina 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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Section 4 - Indications for Use Statement

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)

K180917

Device Name

GC Acrylic Primer

Indications for Use (Describe)

Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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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 there are single quotation marks before and after the letters. The letters are bold and slightly italicized, giving them a dynamic appearance. The background is plain white.

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:Phone:	Mark Heiss, D.D.S.(708) 926-3090
Alternate Contact:	Lori Rietman
Phone:	(708) 926-3092
Fax:	(708) 926-9100
Date Prepared:	April 5, 2018
2. Device Name:
Proprietary Name:	GC ACRYLIC PRIMER
Classification Name:	Resin tooth bonding agent
Device Classification:	21 CFR 872.3200 Class II
Product Code:	KLE

1. Predicate Devices:
  2

Product	Applicant	510(k) No.	Code No	Decision Date	Predicate
ECLIPSE BONDING AGENT	DENTSPLY International	K051707	KLE	06/15/2005	Primary
GRADIA with Composite Primer*	GC America Inc.	K001518	EBF	07/05/2000	Reference
G-BOND PLUS (G-aenial Bond)	GC America Inc.	K082768	KLE	10/21/2008	Reference
UNIFAST LC	GC America Inc.	K890829	EBG	04/17/1989	Reference

*GRADIA kit that includes Composite Primer

4. Description of Device:

5. Packaging

GC Acrylic Primer Package:

Bottle 6mL

6. Shelf Life

Shelf Life and Storage Conditions:

Shelf Life 2 years
Recommended for optimal performance, store in a cool and dark place. 4-25°C (39.2 77.0°F)
1. Indications for Use:

Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)

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8. 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
Application characteristics ●
Refractive index
Bond strength .

9. 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.

Property	Requirements
Appearance	No contamination of foreign matter.
Application characteristics(coating properties)	Equivalent to reference standard.
Refractive index	1.398±0.003
Bond strength	10MPa<

10. Clinical Performance Testing

No clinical testing has been performed on this device.

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Table 5.1 Substantial equivalence to predicate devices

	Applicant device	Primary Device
Productcategory	Resin tooth bonding agentDenture relining, repairing, or rebasing resin	Resin tooth bonding agentDenture relining, repairing, or rebasing resin
Trade name	GC ACRYLIC PRIMER	ECLIPSE BONDING AGENT
Manufacturer	GC Corporation	DENTSPLY International
510(k) No.		K051707
Indications forUse	Increases the adhesiveness of light-curing composites toconventional acrylic resins used in dental laboratory procedures(e.g., modification of denture teeth/denture base resins)	ECLIPSE BONDING AGENT is indicated for use in enhancing the bond of acrylic teethto acrylic removable denture bases.
Productdescription	GC ACRYLIC PRIMER is a primer which raises theadhesiveness to acrylic resin and composite resin.ACRYLIC PRIMER is intended to use for bonding acrylics toacrylic resin, composite to composite resin, and acrylics tocomposite resin respectively.	The device is intended for use in the dental laboratory, by trained technicians, for thepurpose of facilitating a bond between plastic denture teeth and cured denture baseresins.
Mode of action	The device consists of several kinds of monomers to bepolymerized.Polymerization of methacrylate monomers is throughchemical cure.	The ECLIPSE BONDING AGENT is a blend of reactive dimers and oligomers in asolvent vehicle. These reactive entities, once initiated, undergo polymerizationacross the interface between the teeth and the denture base resin to yield a strongand lasting bond. This formulation has been shown to be particularly effective ininitiating and maintaining the bond between acrylic denture teeth and both pour andlight-curable denture base resins.

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Instruction foruse	1. Preparation of adhesion area2. Applying GC Acrylic Primer3. Light curing4. Layering and adhering of resin materials	1. Remove all wax from the teeth, making certain that no residual wax remains onthe teeth.2. Plug in the hot plate and set the temperature to 100 on the graduated faceplate.Allow the hot plate to preheat for at least ten (10) minutes.3. Deglaze the ridge lap of each tooth as a minimal preparation.4. Once the teeth have been ground-in, remove any residual resin from each tooth.5. Shake the bottle of Eclipse Bonding Agent to ensure contents are thoroughlymixed. Pour enough bonding agent into the round metal container to completelysaturate the foam and cover the bottom of the container to a depth of 1 mm.Maintain 1mm depth for all applications.6. Use tweezers to place up to 14 prepared teeth into the holes so that the teeth arepositioned with the ridge lap down and in contact with the liquid. Immediatelyreplace the lid on the container.7. Place the tooth-filled container inside the metal ring of the hot plate until the 40°rectangle on the temperature strip turns green (normally in four (4) to six (6)minutes).8. Using heat-resistant gloves, carefully remove the metal container from the hotplate after the prescribed warming interval and unplug the device.9. Place the teeth on a clean paper towel for about 1minute until any residual liquidevaporates.10. Set the teeth onto the baseplate using Eclipse Set-Up Resin.11. Process the Eclipse Prosthetic Resin according to the Directions For Use
TechnologicalCharacteristics	The bonding mechanism is mechanically and chemically bondwhen monomers are photopolymerized.	The components of ECLIPSE BONDING AGENT have been used in legally marketeddevices or were found safe for dental use. We believe that the prior use of the initiatorcomponents in legally marketed devices, the data provided regarding the modificationsto the marketed device, and the biocompatibility test results support the safety andeffectiveness of ECLIPSE BONDING AGENT for the intended use.

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10. Substantial equivalence:

The curing mechanism of the applicant device and predicate device is 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 device.

11. Differences

The following differences may be noted between GC ACRYLIC PRIMER and the predicate /reference devices.

GC ACRYLIC PRIMER is available for bonding light-cured composite resin and acrylic resin to composites, acrylics, while ECLIPSE BONDING AGENT is available for bonding acrylic resin to acrylic resin.

Slight difference in indications for use verbiage. -

-Regarding the mechanism of polymerization, GC ACRYLIC PRIMER uses a catalyst excited by light, whereas ECLIPSE BONDING AGENT does not use this catalyst.

12. Conclusion

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

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.