(200 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a dental bonding agent, with no mention of AI or ML technologies.
Yes
The device is described as treating "hypersensitive teeth," which is a therapeutic action.
No
The device is a bonding agent used for dental repairs and treatment of hypersensitive teeth, not for diagnosing conditions.
No
The device description clearly states it is a "two component, light-cured bonding agent," which are physical substances (chemicals) and not software. The performance studies also focus on physical properties like bond strength, pH, and refraction index.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a bonding agent for dental procedures, including bonding composites to tooth structure, repairing crowns, and treating hypersensitive teeth. These are all applications performed directly on or within the patient's mouth.
- Device Description: The description reinforces its use as a bonding agent for various dental materials and for treating hypersensitive teeth.
- Anatomical Site: The specified anatomical site is "tooth structure (enamel and dentin)," which is part of the living patient.
- Lack of In Vitro Testing: While there are performance bench tests and non-clinical biocompatibility tests, these are not the same as the in vitro diagnostic tests performed on samples taken from the body (like blood, urine, tissue, etc.) to diagnose or monitor a medical condition. The clinical performance testing section explicitly states "No clinical testing has been performed," which further indicates it's not an IVD that would typically involve testing patient samples.
In Vitro Diagnostics are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition. It is a dental material used for restorative and therapeutic purposes directly on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent available in each of 5 mL liquid bottle or 0.1ml unit dose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Tests:
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).
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.
- Irritation (Direct Primary Oral (Buccal) Irritation Test) - Based on the criteria of the protocol of ISO 10993-10.
The biocompatibility of BZF-29 is acceptable device from the biological evaluation result.
Clinical Performance Testing:
No clinical testing has been performed on this device.
Comparison of Technology:
The bond strengths of the subject device (BZF-29) were compared to the predicate device (G-Premio BOND, K143140).
- Bond strength to tooth structure:
- Enamel: G-Premio BOND: 29.6 (±2.4) MPa; BZF-29: 40.6 (±6.3) MPa (Requirement: >10MPa)
- Dentin: G-Premio BOND: 34.2 (±2.5) MPa; BZF-29: 47.1 (±8.7) MPa (Requirement: >10MPa)
- Bond strength to metal:
- Precious metal: G-Premio BOND: 21.3 (±4.3) MPa; BZF-29: 29.9 (±9.7) MPa (Requirement: >10MPa)
- Non-precious metal: G-Premio BOND: 28.8 (±1.5) MPa; BZF-29: 32.5 (±3.8) MPa (Requirement: >10MPa)
- Bond strength to ceramic and composite:
- Porcelain: G-Premio BOND: 25.8 (±2.3) MPa; BZF-29: 23.3 (±4.3) MPa (Requirement: >10MPa)
- Composite: G-Premio BOND: 34.8 (±2.0) MPa; BZF-29: 30.7 (±2.2) MPa (Requirement: >10MPa)
- Sealing property of dentin tubules: Both predicate and subject devices conformed to the requirement "Should be sealed dentin tubules when observed using SEM".
Key results: 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 components of BZF-29 have already been used in the predicate devices. The bonding mechanism is similar. Based on similarities in intended use, mode of action, chemical composition, and performance testing, BZF-29 is substantially equivalent to the selected predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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.
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, qather 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)
Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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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:
GC America Inc.
3737 W. 127th Street
Alsip, 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.
4
| 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
5
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 | ||||
| Lot.1402081 | BZF-29 | |||
| Lot.1402081 (PRIMER) | ||||
| Lot.1907201G (ADHESIVE) | ||||
| 1 | Bond strength to tooth | |||
| 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 | |||
| 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 | |||
| ceramic and | ||||
| 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 | |||
| dentin tubules | Should be sealed dentin tubules | |||
| 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.
6
| 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 | ||||
| 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.
3.Intraoral repairs of porcelain fused to metal crowns
and composite veneer crowns with metal backing.
4.Intraoral repairs of all ceramic crowns (except
zirconia and alumina), hybrid resin jacket crowns,
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.
6.Treatment of hypersensitive teeth. | 1.Bonding of light cured composites and acid
modified composites (compomers) to tooth
structure.
2.Bonding of dual cured luting and core build up
composites to tooth structure as long as these
materials are light cured.
3.Intraoral repairs of porcelain fused to metal
crowns and composite veneer crowns with metal
backing.
4.Intraoral repairs of all ceramic crowns (except
zirconia and alumina), hybrid resin jacket
crowns, 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. | | | |
| Product
description | BZF-29 is a two component (PRIMER and
ADHESIVE), light-cured bonding agent available in
each 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 liquid
bottle or unit dose. | | | |
| Chemical
Composition | Functional monomers as methacrylates
Acetone solvent
Silica
Water
Accelerator | Functional monomers as methacrylates
Acetone solvent
Silica
Water
Accelerator | | | |
| Biocompatibility | Technological
Characteristics
and Mode of
action | Biocompatibility testing was conducted according to
ISO 10993-1 – Biological evaluation of medical
devices – Part 1: Evaluation and testing within a risk
management process.
- ISO 10993-5:2009 Biological evaluation of
medical devices – Part 5: Tests for in vitro
cytotoxicity.
Statement of Conformity: 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. - ISO 10993-10:2010 Biological evaluation of
medical devices – Part 10: Tests for irritation and
skin sensitization
Statement of Conformity: Base on the criteria of
the protocol, the test article meets
the requirements of the ISO 10993-10 guidelines.
(Sensitization)
Based on the criteria of the protocol, the test
article extracts are considered to be non-irritants
to the buccal tissues of Golden Syrian Hamsters.
(Irritation).
Based on similarities in intended use, mode of
action, chemical composition, and performance
testing, and biocompatibility results, BZF-29 is
substantially equivalent to the selected
predicate device, G-Premio BOND. | The bonding mechanism is applying it to tooth
structure, then bonding chemically and mechanically
by polymerization of uncured methacrylate ester
monomers. | All components in G-Premio BOND have been
used in previous products such as G-ænial
Bond, K082768, and Metal Primer II, K972594.
We conclude that all of the data, such as the
similarity of the components to the predicate
device, the similarity of the principle operation
and the similarity of the performance data,
support the safety and effectiveness of the
applicant new device as intended without
biological evaluation tests, taking into account of
the requirements of ISO 10993-1: 2009. | The bonding mechanism is applying it to tooth
structure, then bonding chemically and
mechanically by polymerization of uncured
methacrylate ester monomers. |