Manufacturer registered with FDA

F&B Technology Co., Ltd.

Sasang-Ku, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10080055Manufacturer
Device types listed
2
Brands and models
2
510(k) clearances
12020–2020
Markets registered in
1United States
Establishments
1South Korea
2020: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What F&B Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
Fit & Brilliant Dental Implant System
2021
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
Fit & Brilliant Dental Implant System
2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names F&B Technology Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
19 Jun 2020K190637Fit & Brilliant Dental Implant SystemDZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
F&B Technology Co., Ltd.FDA reg. 3018077122Sasang-ku Busan, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10080055). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.