(465 days)
Not Found
No
The summary describes a standard dental implant system made of titanium with surface treatment, focusing on material properties, sterilization, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a dental implant system used to support dental prostheses, which is a restorative rather than therapeutic function.
No
Explanation: The device is a dental implant system used for supporting restorations in the mouth. Its function is to replace missing teeth, not to diagnose medical conditions.
No
The device description clearly states it is a physical dental implant made of titanium, a surgical component, and is sterilized by gamma sterilization. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system used to support dental prostheses in the jawbone. This is a surgical and structural function, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium that is surgically inserted into the jaw. This aligns with a medical device used for treatment or structural support, not for analyzing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
In summary, the Fit & Brilliant Dental Implant System is a medical device used for surgical implantation and structural support, not an in vitro diagnostic device.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae, jaw
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)
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 pyrogen test
USP 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
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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.
17-230, #37, Kwaegam-ro, Sasang-ku, (Kwaebop, Inc
Supplies Market) Busan, Korea
Tel. +82-(0)51-319-3214, 1230, 1240 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 14 Dogokro 1-gil
Gangnam-gu, Seoul, Korea (06253)
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: onbix@naver.com |
| 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 |
| 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. | ||
| The principle | Identical to the predicate | This medical product is a fixture 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 series, 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. | ||
| 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 | ||
| diameter | Φ3.9, Φ4.1, Φ4.4, Φ4.8, Φ5.3, Φ5.8, | |
| Φ6.3, Φ6.8 [mm] | Φ3.8, Φ3.9, Φ4.0, Φ4.1, Φ4.5, Φ5.0, | |
| Φ5.5, Φ6.0, Φ6.5, Φ7.0 [mm] | ||
| Implant | ||
| 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 | ||
| treatment | RBM | RBM |
| Gamma | ||
| 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 | ||
| description | Identical to the predicate | This abutment product is used to |
| 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 | |
7
8
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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 pyrogen test USP 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