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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the "Fit & Brilliant Dental Implant System". This document focuses on demonstrating substantial equivalence to a predicate device (U fit Dental Implant System K132956) based on technological characteristics and performance testing to ensure safety and effectiveness. It is not an AI/ML device, and therefore the requested information regarding AI-specific criteria (like MRMC study, stand-alone algorithm performance, training set details, ground truth for AI) is not applicable or present in this document.

Here's the available information relevant to your request, formatted as closely as possible, and noting where information is not applicable (NA) for this type of device submission.

Acceptance Criteria and Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and comparative characteristics. The "reported device performance" refers to the results of non-clinical studies conducted according to these standards.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Standard/Test)	Reported Device Performance (Conclusion)
Biocompatibility	ISO 10993-5 Cytotoxicity	Met (Performed)
	ISO 10993-10 Skin irritation, sensitization	Met (Performed)
Pyrogenicity	USP 29 Biological tests <151> Pyrogen Test	Met (Performed)
Endotoxin	USP <85> BET Endotoxin Testing	Met (Performed)
Mechanical Strength	ISO 14801: Dynamic Fatigue Testing	Met (Performed)
Sterilization	ISO 11737-2: 2009, Sterilization of medical devices	Met (Performed to ensure effective gamma sterilization for the fixture and user steam sterilization for abutments and other components)
	ISO 17665-1, ISO 17665-2, End-User Sterilization	Met (Performed to ensure effective user steam sterilization for abutments)
Packaging Integrity	ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096	Met (Performed, related to accelerated aging and packaging integrity)
Surface Properties	Surface Assessment Evaluation	Met (Performed, ensuring similar surface treatment (RBM) to predicate device for bone integration, and powder for CaP as described in device description)
Material Composition	Ti-6Al-4V ELI ASTM F136	Meets for subject device (Identical to predicate for fixture and most components, some predicate components use Ti-6Al-4V ELI Gr.23)
Indications for Use	Identical to predicate device	Met (Explicitly stated as "Identical to the predicate")
Technological Characteristics	Similar design, connection, components to predicate	Met (Comparison table shows similar design, connection (2.5 Hex. Indentation and 11° Morse taper), and various abutments and accessories)

Note: The document states "To demonstrate substantial equivalence, the following studies have been performed on the new device (K190637) in accordance with these standards." and concludes that the "New device (K190637) is substantially equivalent to the predicate device K132956." This implies that the device met the requirements of these standards.

Additional Requested Information:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as a separate "test set" in the context of an AI/ML device. For dental implant testing, samples would refer to the number of implants/components tested according to each ISO/ASTM standard. This information (specific number of units tested for fatigue, biocompatibility, etc.) is typically found in the detailed study reports, which are not included in this 510(k) summary.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The studies are non-clinical, laboratory-based tests. The manufacturer is F&B Technology Co., Ltd. from Busan, Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device requiring human expert ground truth for classification or diagnosis. The "ground truth" for non-clinical studies is defined by the objective pass/fail criteria of the scientific standards (ISO, ASTM, USP).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human interpretation of data for ground truth establishment in AI/ML studies, not to objective non-clinical performance testing of a physical medical device.

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 physical dental implant device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of human-labeled data for AI/ML. For this device, the "ground truth" is established by the objective, quantifiable endpoints and criteria defined within the referenced international (ISO) and national (ASTM, USP) standards for medical device performance and safety (e.g., cytotoxicity levels, fatigue limits, sterility assurance levels).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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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.

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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 (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)

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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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, IncSupplies Market) Busan, KoreaTel. +82-(0)51-319-3214, 1230, 1240
Contact Person:	Ho Dong, YangOnbix Corporation#821 Samil Plaza, 14 Dogokro 1-gilGangnam-gu, Seoul, Korea (06253)Tel: 82-2-566-3360 / Fax: 82-2-6280-3360Email: 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:

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 isindicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixed bridgework.The Fit & Brilliant Dental Implant Systemis for single and two stage surgicalprocedures. It is intended for delayedloading.
The principle	Identical to the predicate	This medical product is a fixture for dentalimplant that is a surgical component thatinterfaces with the bone of the jaw tosupport a dental prosthesis such as acrown, bridge, denture. It is inserted in thejaw to support and maintain theprosthodontic restorative tooth or denturewhen the tooth is partially or totally lost. Itis made of titanium material (ASTM F136Ti 6Al-4V ELI) that is a widely used in themarket. The surface of the produce istreated with powder for CaP series, and itis designed to connect with thesuperstructure that abutment by internalfastening method. This is disposable
		product sterilized by gamma sterilizationmethod and it prevents re-sterilization orreuse.
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
Implantdiameter	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]
Implantlength	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
Surfacetreatment	RBM	RBM
Gammasterilized	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.
Productdescription	Identical to the predicate	This abutment product is used toattach 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

Regulation Number and Section

§ 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.