GC Acrylic Primer

K180917 · GC America, Inc. · KLE · Nov 20, 2018 · Dental

Device Facts

• Record ID: K180917
• Device Name: GC Acrylic Primer
• Applicant: GC America, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended 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)

Device Story

GC Acrylic Primer is a dental bonding agent used in laboratory settings by technicians to facilitate adhesion between acrylic resins and light-curing composites. The primer is applied to the bonding area, followed by light-curing to initiate polymerization of methacrylate monomers. This chemical and mechanical bonding process enhances the interface between denture teeth and denture base resins. The device is supplied in a 6mL bottle and is intended for professional use to improve the structural integrity of dental prosthetics during modification, relining, or repair.

Clinical Evidence

No clinical testing has been performed on this device. Bench testing confirmed conformance to specifications, including appearance, application characteristics, refractive index (1.398±0.003), and bond strength (>10MPa). Biocompatibility was assessed per ISO 10993-1:2009 and ISO 10993-5, confirming the device is not cytotoxic.

Technological Characteristics

Resin tooth bonding agent consisting of methacrylate monomers. Bonding mechanism involves chemical and mechanical adhesion via photopolymerization. Refractive index: 1.398±0.003. Bond strength: >10MPa. Shelf life: 2 years when stored at 4-25°C.

Indications for Use

Indicated for dental laboratory procedures requiring increased adhesiveness between light-curing composites and conventional acrylic resins, such as modification of denture teeth or denture base resins.

Regulatory Classification

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.

Predicate Devices

• ECLIPSE BONDING AGENT (K051707)

Reference Devices

• GRADIA with Composite Primer (K001518)
• G-BOND PLUS (G-aenial Bond) (K082768)
• UNIFAST LC (K890829)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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 [phone]
FAX [phone]
www.gcamerica.com

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

| Contact Person:<br>Phone: | Mark Heiss, D.D.S.<br>[phone] |
|---------------------------|--------------------------------------|
| Alternate Contact: | Lori Rietman |
| Phone: | [phone] |
| Fax: | [phone] |
| 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 |

- 3. 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:

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.

#### 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)
- 7. 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<br>(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 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>category | Resin tooth bonding agent<br>Denture relining, repairing, or rebasing resin | Resin tooth bonding agent<br>Denture relining, repairing, or rebasing resin |
| Trade name | GC ACRYLIC PRIMER | ECLIPSE BONDING AGENT |
| Manufacturer | GC Corporation | DENTSPLY International |
| 510(k) No. | | K051707 |
| Indications for<br>Use | Increases the adhesiveness of light-curing composites to<br>conventional acrylic resins used in dental laboratory procedures<br>(e.g., modification of denture teeth/denture base resins) | ECLIPSE BONDING AGENT is indicated for use in enhancing the bond of acrylic teeth<br>to acrylic removable denture bases. |
| Product<br>description | GC ACRYLIC PRIMER is a primer which raises the<br>adhesiveness to acrylic resin and composite resin.<br>ACRYLIC PRIMER is intended to use for bonding acrylics to<br>acrylic resin, composite to composite resin, and acrylics to<br>composite resin respectively. | The device is intended for use in the dental laboratory, by trained technicians, for the<br>purpose of facilitating a bond between plastic denture teeth and cured denture base<br>resins. |
| Mode of action | The device consists of several kinds of monomers to be<br>polymerized.<br>Polymerization of methacrylate monomers is through<br>chemical cure. | The ECLIPSE BONDING AGENT is a blend of reactive dimers and oligomers in a<br>solvent vehicle. These reactive entities, once initiated, undergo polymerization<br>across the interface between the teeth and the denture base resin to yield a strong<br>and lasting bond. This formulation has been shown to be particularly effective in<br>initiating and maintaining the bond between acrylic denture teeth and both pour and<br>light-curable denture base resins. |

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