Fit & Brilliant Dental Implant System

K190637 · F&B Technology Co., Ltd. · DZE · Jun 19, 2020 · Dental

Device Facts

• Record ID: K190637
• Device Name: Fit & Brilliant Dental Implant System
• Applicant: F&B Technology Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fit & Brilliant Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Fit &Brilliant Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Device Story

Dental implant system comprising titanium fixtures and various abutments; interfaces with jaw bone to support dental prostheses (crowns, bridges, dentures). Fixtures inserted into jaw; abutments attached via internal fastening (2.5 Hex indentation and 11-degree Morse taper). Used by dental professionals in clinical settings for single or two-stage surgical procedures. Fixtures are gamma-sterilized and disposable; abutments require user steam sterilization (autoclave). System provides structural support for restorative dentistry; benefits patients by replacing lost teeth and restoring oral function.

Clinical Evidence

Bench testing only. Testing included ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), USP 29 <151> (pyrogen), USP <85> (endotoxin), ISO 14801 (dynamic fatigue), ISO 11737-2, ISO 17665-1/2 (sterilization), and ASTM standards for packaging (F88, F1140, F1929, F2096).

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Design: Submerged fixture, 2.5 Hex indentation, 11-degree Morse taper. Surface: RBM treated. Fixture diameters: 3.9-6.8mm. Lengths: 7-14.5mm. Sterilization: Gamma (fixtures), Steam/Autoclave (abutments).

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Suitable for single or two-stage surgical procedures with delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• U fit Dental Implant System (K132956)

Submission Summary (Full Text)

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June 19, 2020

F&B Technology Co., Ltd. % Yang Ho Dong Manager Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul 46977 REPUBLIC OF KOREA

Re: K190637

Trade/Device Name: Fit & Brilliant Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 8, 2020 Received: June 18, 2020

Dear Ho Dong Yang:

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.

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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 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 medical devices and radiation-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 Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190637

Device Name Fit & Brilliant Dental Implant System

#### Indications for Use (Describe)

The Fit & Brilliant Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Fit &Brilliant Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 510(k) SUMMARY K190637

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.

| Submitter Information: | F&B Technology Co., Ltd.<br>17-230, #37, Kwaegam-ro, Sasang-ku, (Kwaebop, Inc<br>Supplies Market) Busan, Korea<br>Tel. [phone], 1230, 1240 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang<br>Onbix Corporation<br>#821 Samil Plaza, 14 Dogokro 1-gil<br>Gangnam-gu, Seoul, Korea (06253)<br>Tel: *82-2-566-3360 / Fax: *82-2-6280-3360<br>Email: [e-mail] |
| Date Summary Prepared: | June 19, 2020 |
| Device Information: | |
| Trade Name(s): | Fit & Brilliant Dental Implant System |
| Classification Name: | Endosseous Dental Implant |
| Panel: | dental |
| Product Code & Regulation: | DZE / NHA |

# Primary Predicate Device Information:

K132956 / U fit Dental Implant System

# DeviceDescription:

This medical product is for dental implant that is a surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. It is inserted in the jaw to support and maintain the prosthodontic restorative tooth or denture when the tooth is partially or totally lost. It is made of titanium material (ASTM F136 Ti 6Al-4V ELI) that is a widely used in the market. The surface of the produce is treated with powder for CaP, and it is designed to connect with the superstructure that abutment by internal fastening method. This is disposable product sterilized by gamma sterilization method and it prevents re-sterilization or reuse.

#### Indications for Use:

The Fit & Brilliant Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Fit &Brilliant Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

#### Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

- * indications for use
- * technological characteristics
- * performanceproperties

# Summary of the technological characteristics compared to the predicate device

new device is substantially equivalent to the predicate device in its technological characteristics stated in below comparison table

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# Comparative table

| 1) Fixture | | |
|----------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device | Predicate device |
| Device name | Fit & Brilliant Dental Implant System | U fit Dental Implant System |
| 510(k) number | K190637 | K132956 |
| Manufacturer | F&B Technology Co., Ltd | T Strong, Inc. |
| Intended use | Identical to the predicate | The U fit Dental Implant System is<br>indicated for use in partially or fully<br>edentulous mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including; cemented retained,<br>screw retained, or overdenture<br>restorations, and terminal or intermediate<br>abutment support for fixed bridgework.<br>The Fit & Brilliant Dental Implant System<br>is for single and two stage surgical<br>procedures. It is intended for delayed<br>loading. |
| The principle | Identical to the predicate | This medical product is a fixture for dental<br>implant that is a surgical component that<br>interfaces with the bone of the jaw to<br>support a dental prosthesis such as a<br>crown, bridge, denture. It is inserted in the<br>jaw to support and maintain the<br>prosthodontic restorative tooth or denture<br>when the tooth is partially or totally lost. It<br>is made of titanium material (ASTM F136<br>Ti 6Al-4V ELI) that is a widely used in the<br>market. The surface of the produce is<br>treated with powder for CaP series, and it<br>is designed to connect with the<br>superstructure that abutment by internal<br>fastening method. This is disposable |
| | | product sterilized by gamma sterilization<br>method and it prevents re-sterilization or<br>reuse. |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI ASTM F136 |
| Design | Image: dental implant | Image: dental implant |
| Fixture Type | Submerged Type | Submerged Type |
| Implant<br>diameter | Φ3.9, Φ4.1, Φ4.4, Φ4.8, Φ5.3, Φ5.8,<br>Φ6.3, Φ6.8 [mm] | Φ3.8, Φ3.9, Φ4.0, Φ4.1, Φ4.5, Φ5.0,<br>Φ5.5, Φ6.0, Φ6.5, Φ7.0 [mm] |
| Implant<br>length | 7, 8.5, 10, 11.5, 13, 14.5 [mm] | 7, 8.5, 10, 11.5, 13, 14.5 [mm] |
| Connection | 2.5 Hex. Indentation and 11[°] Morse taper | 2.5 Hex. Indentation and 11[°] Morse taper |
| Components | Various abutments and accessories | Various abutments and accessories |
| Surface<br>treatment | RBM | RBM |
| Gamma<br>sterilized | Yes | Yes |
| Product Code | DZE | DZE |

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| 2) Abutment | | |
|------------------------|---------------------------------------|--------------------------------------------------------------------------|
| | Subject device | Predicate device |
| Device name | Fit & Brilliant Dental Implant System | U fit Dental Implant System |
| 510(k) number | NA | K132956 |
| Manufacturer | F&B Technology Co., Ltd | T Strong, Inc. |
| Product<br>description | Identical to the predicate | This abutment product is used to<br>attach a crown, bridge, or removable |

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| | | denture to the dental implant fixture. It | |
|-------------------|-------------------------------------------------|-------------------------------------------------|--|
| | | is made of titanium material (ASTM | |
| | | F136 Ti 6Al-4V ELI) that is a widely | |
| | | used in the market. It is designed to | |
| | | connect with the dental fixture by | |
| | | internal fastening method. This is a | |
| | | disposable product requires user | |
| | | sterilization with autoclave and it | |
| | | prevents re-sterilization or reuse. | |
| Product Code | NHA | NHA | |
| Cover Screw | | | |
| Design | Image: Cover Screw Design 1 | Image: Cover Screw Design 2 | |
| Intended use | To provide sealing effect for fixture | To provide sealing effect for fixture | |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI Gr.23 | |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user | |
| | Abutment Screw | | |
| Design | Image: Abutment Screw Design 1 | Image: Abutment Screw Design 2 | |
| Intended use | To connect abutment to fixture | To connect abutment to fixture | |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI ASTM F136 | |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user | |
| Healing Abutment | | | |
| Design | Image: Dental abutment | Image: Dental abutment | |
| Intended use | To help the soft tissue of gum naturally formed | To help the soft tissue of gum naturally formed | |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI Gr.23 | |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user | |
| Solid Abutment | | | |
| Design | Image: Dental abutment | Image: Dental abutment | |
| Intended use | Cement retained restoration | Cement retained restoration | |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI Gr.23 | |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user | |
| Transfer Abutment | | | |
| Design | Image: Dental abutment | Image: Dental abutment | |
| Intended use | Cement retained restoration | Cement retained restoration | |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI Gr.23 | |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user | |
| Angled Abutment | | | |
| Design | Image: Dental Implant | Image: Dental Implant | |
| Intended use | Cement retained restoration (15, 25[°]) | Cement retained restoration (15, 25[°]) | |
| Material | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI ASTM F136 | |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user | |
| | | | |
| | | | |
| | | | |

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# Non-Clinical Study performance

To demonstrate substantial equivalence, the following studies have been performed on the new device (K190637) in accordance with these standards:

ISO 10993-5 cytotoxicity ISO 10993-10 skin irritation, sensitization ISO10993-10:skinirritation,sensitization USP 29 Biological tests <151> pyrogen test USP<85> BET endotoxin testing ISO 14801: dynamic fatique testing ISO 11737-2: 2009, Sterilization of medical devices ISO 17665-1, ISO 17665-2, End-User Sterilization ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096: accelerated aging Surface Assessment Evaluation

#### Conclusion

New device (K190637) has the same device characteristics as the predicate device, Based on the information provided in this summary we conclude that New device (K190637) is substantially equivalent to the predicate device K132956