BZF-29

K200682 · GC America, Inc. · KLE · Oct 2, 2020 · Dental

Device Facts

• Record ID: K200682
• Device Name: BZF-29
• Applicant: GC America, Inc.
• Product Code: KLE · Dental
• Decision Date: Oct 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for: 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

BZF-29 is a two-component (primer and adhesive), light-cured dental bonding agent; used by dental professionals in clinical settings. Input: tooth structure or restorative material surfaces. Operation: primer and adhesive applied to surfaces; polymerization of methacrylate ester monomers creates chemical and mechanical bond. Output: bonded restorative material or sealed dentin tubules. Benefit: enables adhesion of composites/crowns and treats tooth hypersensitivity. Healthcare providers use output to restore tooth structure or repair dental prosthetics.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility assessments. Bench testing compared bond strengths (enamel, dentin, metal, ceramic, composite) and dentin tubule sealing against the predicate. Results showed BZF-29 bond strengths (e.g., 40.6 MPa enamel, 47.1 MPa dentin) were equivalent or superior to the predicate. Biocompatibility testing followed ISO 10993-1, including L929 Agar Diffusion (cytotoxicity), Direct Buehler (sensitization), and Direct Primary Oral Irritation tests, confirming the device is non-cytotoxic and non-irritating.

Technological Characteristics

Two-component (primer and adhesive) light-cured resin bonding agent. Composition: methacrylate functional monomers, acetone solvent, silica, water, accelerator. Form factor: 5 mL bottles or 0.1 mL unit doses. Sensing/actuation: chemical/mechanical bonding via light-activated polymerization. Biocompatibility: ISO 10993-1, 10993-5, 10993-10 compliant.

Indications for Use

Indicated for dental patients requiring bonding of light-cured/acid-modified composites, dual-cured luting/core build-up composites, intraoral repair of various crowns (porcelain-fused-to-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-Premio BOND (K143140)

Reference Devices

• G-ænial Bond (K082768)
• Metal Primer II (K972594)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 2, 2020

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

Re: K200682

Trade/Device Name: Bzf-29 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: June 30, 2020 Received: July 6, 2020

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Section 4 - Indication 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) K200682

Device Name

BZF-29

Indications for Use (Describe)

BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for:

- 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.

| 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.

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image shows the logo for GCC, which is a teal color. Below the logo is the number 1 in black. The logo is stylized with quotation marks around the letters GCC.

Image /page/3/Picture/1 description: The image shows a graphic design with geometric shapes. On the left, there's a partial outline of a triangle, represented by two lines. To the right of the triangle, there are seven small, tilted rectangles arranged in a pattern resembling a cascade or a descending staircase. The rectangles and the lines of the triangle are all in the same teal color.

# 510(k) Summary

| 1. | Submitter Information:<br>GC America Inc.<br>3737 W. 127th Street<br>Alsip, IL 60803 | |
|----|--------------------------------------------------------------------------------------|--------------------------------------|
| | Contact Person:<br>Phone: | Mark Heiss, D.D.S.<br>[phone] |
| | Email: | [e-mail] |
| | Alternate Contact: | Lori Rietman |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Date Prepared: | October 1, 2020 |
| 2. | Device Name: | |
| | Proprietary Name: | BZF-29 |
| | Classification Name: | Resin tooth bonding agent |
| | Device Classification: | Class II, 872.3200 |
| | Product Code: | KLF |

- 3. Predicate Devices:

| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|---------------|-----------------|------------|---------|-----------|---------------|
| G-Premio BOND | GC America Inc. | K143140 | KLE | Primary | 04/20/2015 |

#### 4. Description of Device:

BZF-29 is a two component, light-cured bonding agent to bond light-cured composite resins to tooth structure, composites, hybrid ceramics, ceramics and metal surfaces, and for the treatment of hypersensitive teeth.

#### 5. Indications for Use:

BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for:

- 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.

K200682

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| 6. | Packaging | |
|----|-----------------------------------|----------|
| | BZF-29 Bottle Package: | |
| | - PRIMER liquid (Bottle / 5 mL) | QTY: 1 |
| | - ADHESIVE liquid (Bottle / 5 mL) | QTY: 1 |
| | - Disposable applicator | QTY: 100 |
| | - Disposable dispensing dish | QTY: 20 |
| | | |

BZF-29 Unit Dose Package:

- PRIMER liquid (Unit Dose / 0.1 mL) OTY: 50
- ADHESIVE liquid (Unit Dose / 0.1 mL) OTY: 50
- Disposable applicator QTY: 100
- 7. Shelf Life and Storage Conditions:
- Shelf Life 2 years
- Recommended for optimal performance, store at temperature of 4-25°C (39.2-77.0°F)

#### 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
- Curing property
- · Application characteristics
- Color
- pH
- · Refraction index

The applicant device complies with all the requirements of 1AB-1500- 3-10706 (Company specification) (see table below).

| | Property | Requirements |
|---|-----------------------------|------------------------------------------------------------|
| 1 | Appearance | Should be homogenous and free from foreign matters |
| 2 | Curing property | Should be cured and formed film |
| 3 | Application characteristics | Should be formed even and homogenous coat. |
| 4 | Color | Yellow opaque for PRIMER, Yellow for ADHESIVE |
| 5 | pH (only for PRIMER) | 1.3 to 1.8 |
| 6 | Refraction index | 1.4080 to 1.4110 for PRIMER, 1.4905 to 1.4935 for ADHESIVE |

- 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.

### Cytotoxicity (L929 Agar Diffusion Test)

Based on the criteria of the protocol of ISO 10993-5

### Sensitivity (Direct Buehler Sensitization Test)

Based on the criteria of the protocol of ISO 10993-10

- 2

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# Irritation (Direct Primary Oral (Buccal) Irritation Test)

Based on the criteria of the protocol of ISO 10993-10

The device is a dental restorative product and the device does come in contact with the body tissues (tooth enamel, dentin) for more than 24 hours.

In conclusion, biocompatibility of BZF-29 is acceptable device from the biological evaluation result.

#### 10. Clinical Performance Testing

No clinical testing has been performed on this device.

## 11. Comparison of Technology

The specifications that are important to determine substantial equivalency of a dental adhesive system are bond strengths associated to tooth structure (enamel and dentin) and other substrates. Furthermore, as shown in "Indication for use" it is also important to evaluate the equivalence of sealing property of dentin tubules.

| Property | | Requirements | Test results | |
|----------|----------------------------------------------|------------------------------------------------------------|------------------------------|-----------------------------------------------------------|
| | | | G-Premio BOND<br>Lot.1402081 | BZF-29<br>Lot.1402081 (PRIMER)<br>Lot.1907201G (ADHESIVE) |
| 1 | Bond strength to tooth<br>structure | >10MPa for enamel | 29.6 (±2.4) | 40.6 (±6.3) |
| | | >10MPa for dentin | 34.2 (±2.5) | 47.1 (±8.7) |
| 2 | Bond strength to<br>metal | >10MPa for precious metal | 21.3 (±4.3) | 29.9 (±9.7) |
| | | >10MPa for non-precious metal | 28.8 (±1.5) | 32.5 (±3.8) |
| 3 | Bond strength to<br>ceramic and<br>composite | >10MPa for porcelain | 25.8 (±2.3) | 23.3 (±4.3) |
| | | >10MPa for composite | 34.8 (±2.0) | 30.7 (±2.2) |
| 4 | Sealing property of<br>dentin tubules | Should be sealed dentin tubules<br>when observed using SEM | Conformed | Conformed |
| Judgment | | | Conformed | Conformed |

The bond strengths as noted above compare the predicate device (G-Premio BOND, K143140) to the subject device. In both enamel and dentin bonding, the results are equivalent. In addition, bond strength of subject device to other substrates was equivalent to the predicate bond strengths to enamel and dentin.

All the components of the applicant device, BZF-29, 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

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

The following differences may be noted between BZF-29 and the predicate devices:

- · BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent and G-Premio Bond is a one component, light-cured bonding agent. The additional component in BSF-29 is to enhance the bond strength.
# 12. Conclusion

Based on similarities in intended use, mode of action, chemical composition, and performance testing, BZF-29 is substantially equivalent to the selected predicate device, G-Premio BOND.

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| | Applicant device | Primary Device | | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product category | Resin tooth bonding agent, Class II | Resin tooth bonding agent, Class II | | | |
| Trade name | BZF-29 | G-Premio BOND | | | |
| 510(k) | K200682 | K143140 | | | |
| Product Code | KLE | KLE | | | |
| Prescription/OTC | RX Only | RX Only | | | |
| Manufacturer | GC Corporation | GC Corporation | | | |
| Indication for use | 1. Bonding of light cured composites and acid<br>modified composites (compomers) to tooth<br>structure.<br>2. Bonding of dual cured luting and core build up<br>composites to tooth structure as long as these<br>materials are light cured.<br>3.Intraoral repairs of porcelain fused to metal crowns<br>and composite veneer crowns with metal backing.<br>4.Intraoral repairs of all ceramic crowns (except<br>zirconia and alumina), hybrid resin jacket crowns,<br>CAD/CAM hybrid resin crowns and composites.<br>5.Intraoral repairs of porcelain fused to zirconia<br>crowns, porcelain fused to alumina crowns and full<br>zirconia crowns.<br>6.Treatment of hypersensitive teeth. | 1.Bonding of light cured composites and acid<br>modified composites (compomers) to tooth<br>structure.<br>2.Bonding of dual cured luting and core build up<br>composites to tooth structure as long as these<br>materials are light cured.<br>3.Intraoral repairs of porcelain fused to metal<br>crowns and composite veneer crowns with metal<br>backing.<br>4.Intraoral repairs of all ceramic crowns (except<br>zirconia and alumina), hybrid resin jacket<br>crowns, CAD/CAM hybrid resin crowns and<br>composites.<br>5.Intraoral repairs of porcelain fused to zirconia<br>crowns, porcelain fused to alumina crowns and<br>full zirconia crowns.<br>6. Treatment of hypersensitive teeth. | | | |
| Product<br>description | BZF-29 is a two component (PRIMER and<br>ADHESIVE), light-cured bonding agent available in<br>each of 5 mL liquid bottle or 0.1ml unit dose. | G-Premio BOND is a one component, light-<br>cured bonding agent available in a 5 mL liquid<br>bottle or unit dose. | | | |
| Chemical<br>Composition | Functional monomers as methacrylates<br>Acetone solvent<br>Silica<br>Water<br>Accelerator | Functional monomers as methacrylates<br>Acetone solvent<br>Silica<br>Water<br>Accelerator | | | |
| Biocompatibility | Technological<br>Characteristics<br>and Mode of<br>action | Biocompatibility testing was conducted according to<br>ISO 10993-1 – Biological evaluation of medical<br>devices – Part 1: Evaluation and testing within a risk<br>management process.<br>- ISO 10993-5:2009 Biological evaluation of<br>medical devices – Part 5: Tests for in vitro<br>cytotoxicity.<br>Statement of Conformity: Based on the criteria<br>of the protocol and the ISO 10993-5 guidelines,<br>the test article meets the requirements of the test<br>and is not considered to have a cytotoxic effect.<br>- ISO 10993-10:2010 Biological evaluation of<br>medical devices – Part 10: Tests for irritation and<br>skin sensitization<br>Statement of Conformity: Base on the criteria of<br>the protocol, the test article meets<br>the requirements of the ISO 10993-10 guidelines.<br>(Sensitization)<br>Based on the criteria of the protocol, the test<br>article extracts are considered to be non-irritants<br>to the buccal tissues of Golden Syrian Hamsters.<br>(Irritation).<br>Based on similarities in intended use, mode of<br>action, chemical composition, and performance<br>testing, and biocompatibility results, BZF-29 is<br>substantially equivalent to the selected<br>predicate device, G-Premio BOND. | The bonding mechanism is applying it to tooth<br>structure, then bonding chemically and mechanically<br>by polymerization of uncured methacrylate ester<br>monomers. | All components in G-Premio BOND have been<br>used in previous products such as G-ænial<br>Bond, K082768, and Metal Primer II, K972594.<br><br>We conclude that all of the data, such as the<br>similarity of the components to the predicate<br>device, the similarity of the principle operation<br>and the similarity of the performance data,<br>support the safety and effectiveness of the<br>applicant new device as intended without<br>biological evaluation tests, taking into account of<br>the requirements of ISO 10993-1: 2009. | The bonding mechanism is applying it to tooth<br>structure, then bonding chemically and<br>mechanically by polymerization of uncured<br>methacrylate ester monomers. |