G-Premio BOND

K143140 · GC America, Inc. · KLE · Apr 20, 2015 · Dental

Device Facts

• Record ID: K143140
• Device Name: G-Premio BOND
• Applicant: GC America, Inc.
• Product Code: KLE · Dental
• Decision Date: Apr 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 are light cured. 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, CAD/CAM hybrid resin crowns and composites. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns. Treatment of hypersensitive teeth.

Device Story

G-Premio BOND is a one-component, light-cured dental adhesive; supplied in 5 mL bottles or unit doses. Applied by dental professionals to tooth structure or restorative surfaces (metals, ceramics, composites); functions via chemical and mechanical bonding through polymerization of methacrylate ester monomers. Used for bonding restorative materials and treating tooth hypersensitivity. Output is a cured adhesive film providing structural bond; clinical benefit includes restoration retention and reduction of dentin hypersensitivity.

Clinical Evidence

Bench testing only. Performance evaluated against company specification AB-15-Q-301-631(1). Metrics included bond strength (>10MPa for enamel, dentin, metal, porcelain, composite, and zirconia), appearance, curing property, application characteristics, and SEM observation of dentin tubule sealing. Results demonstrated equivalence to predicate device.

Technological Characteristics

One-component, light-cured resin bonding agent. Composition includes methacrylate ester monomers. Polymerization-based bonding mechanism. Form factor: 5 mL liquid bottle or unit dose. Shelf life: 2 years. Storage: 1-25°C. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restorative procedures, including bonding of light-cured/dual-cured composites to tooth structure, intraoral repair of various crown/veneer types (metal, ceramic, hybrid resin), and treatment of hypersensitive teeth.

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

• G-ænial Bond (K082768)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.
- 3. 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.
- 5. 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: | [phone] |
| Fax: | [phone] |

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.
- 4. 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 foreign<br>matters |
| 2 | Curing property | Should be cured and formed film |
| 3 | Bond strength to<br>tooth structure | >10MPa for enamel<br>>10MPa for dentin |
| 4 | Bond strength to<br>metal | >10MPa for precious metal<br>>10MPa for non-precious metal |
| 5 | Bond strength to<br>ceramic and<br>composite | >10MPa for porcelain<br>>10MPa for composite<br>>10MPa for zirconia |
| 6 | Application<br>characteristics | Should be formed even and homogenous<br>coat. |
| 7 | Sealing property<br>of dentin tubules | Should be sealed dentin tubules when<br>observed 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) .
- 9. 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).