(200 days)
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.
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.
The provided document is a 510(k) premarket notification for a dental bonding agent, BZF-29, seeking substantial equivalence to a predicate device, G-Premio BOND. The document details performance bench tests and comparisons to establish this equivalency, but it does not describe a study involving human subjects or AI assistance. Instead, the "performance" described refers to material properties and bond strengths as mechanical measures.
Therefore, many of the requested criteria regarding human readers, AI assistance, ground truth establishment methods for training, and detailed study specifics are not applicable or cannot be extracted from this document, as it focuses on demonstrating product characteristics through bench and biocompatibility testing against a predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Requirements) | Predicate Device (G-Premio BOND) Performance | Subject Device (BZF-29) Performance |
|---|---|---|---|
| Appearance | Should be homogenous and free from foreign matters | Not explicitly stated for predicate; "Conformed" for overall judgment | Conformed |
| Curing property | Should be cured and formed film | Not explicitly stated for predicate; "Conformed" for overall judgment | Conformed |
| Application characteristics | Should be formed even and homogenous coat. | Not explicitly stated for predicate; "Conformed" for overall judgment | Conformed |
| Color | Yellow opaque for PRIMER, Yellow for ADHESIVE | Not explicitly stated for predicate; "Conformed" for overall judgment | Yellow opaque for PRIMER, Yellow for ADHESIVE |
| pH (only for PRIMER) | 1.3 to 1.8 | Not explicitly stated for predicate; "Conformed" for overall judgment | 1.3 to 1.8 (within range) |
| Refraction index | 1.4080 to 1.4110 for PRIMER, 1.4905 to 1.4935 for ADHESIVE | Not explicitly stated for predicate; "Conformed" for overall judgment | 1.4080 to 1.4110 for PRIMER, 1.4905 to 1.4935 for ADHESIVE (within range) |
| Bond strength to tooth structure (enamel) | >10MPa | 29.6 (±2.4) MPa | 40.6 (±6.3) MPa |
| Bond strength to tooth structure (dentin) | >10MPa | 34.2 (±2.5) MPa | 47.1 (±8.7) MPa |
| Bond strength to metal (precious) | >10MPa | 21.3 (±4.3) MPa | 29.9 (±9.7) MPa |
| Bond strength to metal (non-precious) | >10MPa | 28.8 (±1.5) MPa | 32.5 (±3.8) MPa |
| Bond strength to ceramic (porcelain) | >10MPa | 25.8 (±2.3) MPa | 23.3 (±4.3) MPa |
| Bond strength to composite | >10MPa | 34.8 (±2.0) MPa | 30.7 (±2.2) MPa |
| Sealing property of dentin tubules | Should be sealed dentin tubules when observed using SEM | Conformed | Conformed |
| Biocompatibility - Cytotoxicity | Not considered to have a cytotoxic effect (Based on ISO 10993-5) | Conformed | Conformed (acceptable device from the biological evaluation result) |
| Biocompatibility - Sensitivity | Meets requirements of ISO 10993-10 (Sensitization) | Conformed | Conformed (meets requirements of ISO 10993-10) |
| Biocompatibility - Irritation | Non-irritant to buccal tissues (Based on ISO 10993-10) | Conformed (test article extracts are considered non-irritants to buccal tissues) | Conformed (acceptable device from the biological evaluation result for irritation) |
Notes on the Table:
- For "Appearance," "Curing property," "Application characteristics," "Color," "pH," and "Refraction index," the document states that the applicant device complies with all the requirements of 1AB-1500-3-10706 (Company specification) and then lists the specific requirements. The predicate device's performance against these specific criteria is not individually detailed but is implied to be "Conformed" for overall comparison purposes to establish substantial equivalence.
- The acceptance criteria for bond strength are stated as ">10MPa" for all categories.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of teeth/samples tested) for each specific bench test (e.g., bond strength measurements). It refers to the results as statistical averages with standard deviations, implying multiple samples were used for each measurement.
The data provenance is not specified beyond "bench tests" conducted by the manufacturer, presumably in a laboratory setting. There is no information on country of origin or whether it was retrospective or prospective, as these terms are typically used for clinical studies involving patients, which is not the case here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for the test set is established by objective physical and chemical measurements (e.g., MPa for bond strength, pH values, visual checks for homogeneity, SEM for dentin tubules) and adherence to ISO standards for biocompatibility, not by expert consensus or interpretation of images.
4. Adjudication method for the test set
Not applicable. The tests are based on objective, quantifiable measurements against pre-defined specifications and ISO standards, not on subjective assessment requiring adjudication among experts.
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
Not applicable. This is a material science study of a dental bonding agent, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material science study, not an AI algorithm.
7. The type of ground truth used
The ground truth is based on:
- Company specifications (1AB-1500-3-10706): For properties like appearance, curing, application characteristics, color, pH, and refraction index.
- Quantitative measurements: For bond strength (measured in MPa).
- Microscopic observation: For sealing property of dentin tubules (using SEM).
- International Standards (ISO 10993 series): For biocompatibility, specifically ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitivity, irritation).
8. The sample size for the training set
Not applicable. This document describes performance validation against a predicate device and established standards, not the training of a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is mentioned or implied.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
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510(k) Summary
| 1. | Submitter Information:GC America Inc.3737 W. 127th StreetAlsip, IL 60803 | |
|---|---|---|
| Contact Person:Phone: | Mark Heiss, D.D.S.(708) 926-3090 | |
| Email: | mark.heiss@gc.dental | |
| Alternate Contact: | Lori Rietman | |
| Phone: | (708) 926-3092 | |
| Fax: | (708) 925-0373 | |
| 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 |
-
- 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.
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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
-
- 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 |
-
- 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.
- Non-Clinical Performance Testing
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 BONDLot.1402081 | BZF-29Lot.1402081 (PRIMER)Lot.1907201G (ADHESIVE) | |||
| 1 | Bond strength to toothstructure | >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 tometal | >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 toceramic andcomposite | >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 ofdentin tubules | Should be sealed dentin tubuleswhen 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 acidmodified composites (compomers) to toothstructure.2. Bonding of dual cured luting and core build upcomposites to tooth structure as long as thesematerials are light cured.3.Intraoral repairs of porcelain fused to metal crownsand composite veneer crowns with metal backing.4.Intraoral repairs of all ceramic crowns (exceptzirconia and alumina), hybrid resin jacket crowns,CAD/CAM hybrid resin crowns and composites.5.Intraoral repairs of porcelain fused to zirconiacrowns, porcelain fused to alumina crowns and fullzirconia crowns.6.Treatment of hypersensitive teeth. | 1.Bonding of light cured composites and acidmodified composites (compomers) to toothstructure.2.Bonding of dual cured luting and core build upcomposites to tooth structure as long as thesematerials are light cured.3.Intraoral repairs of porcelain fused to metalcrowns and composite veneer crowns with metalbacking.4.Intraoral repairs of all ceramic crowns (exceptzirconia and alumina), hybrid resin jacketcrowns, CAD/CAM hybrid resin crowns andcomposites.5.Intraoral repairs of porcelain fused to zirconiacrowns, porcelain fused to alumina crowns andfull zirconia crowns.6. Treatment of hypersensitive teeth. | |||
| Productdescription | BZF-29 is a two component (PRIMER andADHESIVE), light-cured bonding agent available ineach of 5 mL liquid bottle or 0.1ml unit dose. | G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquidbottle or unit dose. | |||
| ChemicalComposition | Functional monomers as methacrylatesAcetone solventSilicaWaterAccelerator | Functional monomers as methacrylatesAcetone solventSilicaWaterAccelerator | |||
| Biocompatibility | TechnologicalCharacteristicsand Mode ofaction | Biocompatibility testing was conducted according toISO 10993-1 – Biological evaluation of medicaldevices – Part 1: Evaluation and testing within a riskmanagement process.- ISO 10993-5:2009 Biological evaluation ofmedical devices – Part 5: Tests for in vitrocytotoxicity.Statement of Conformity: Based on the criteriaof the protocol and the ISO 10993-5 guidelines,the test article meets the requirements of the testand is not considered to have a cytotoxic effect.- ISO 10993-10:2010 Biological evaluation ofmedical devices – Part 10: Tests for irritation andskin sensitizationStatement of Conformity: Base on the criteria ofthe protocol, the test article meetsthe requirements of the ISO 10993-10 guidelines.(Sensitization)Based on the criteria of the protocol, the testarticle extracts are considered to be non-irritantsto the buccal tissues of Golden Syrian Hamsters.(Irritation).Based on similarities in intended use, mode ofaction, chemical composition, and performancetesting, and biocompatibility results, BZF-29 issubstantially equivalent to the selectedpredicate device, G-Premio BOND. | The bonding mechanism is applying it to toothstructure, then bonding chemically and mechanicallyby polymerization of uncured methacrylate estermonomers. | All components in G-Premio BOND have beenused in previous products such as G-ænialBond, K082768, and Metal Primer II, K972594.We conclude that all of the data, such as thesimilarity of the components to the predicatedevice, the similarity of the principle operationand the similarity of the performance data,support the safety and effectiveness of theapplicant new device as intended withoutbiological evaluation tests, taking into account ofthe requirements of ISO 10993-1: 2009. | The bonding mechanism is applying it to toothstructure, then bonding chemically andmechanically by polymerization of uncuredmethacrylate ester monomers. |
§ 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.