Manufacturer registered with FDA

T Strong, Inc.

Gimhae-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10086215Manufacturer

Device types listed: 3
Brands and models: 21
510(k) clearances: 12014–2014
Markets registered in: 22 registrations outside the US
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name T Strong, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: South KoreaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	T Strong, Inc.	1 clearances	2014–2014	Below
Taiwan	TFDA	Manufacturer	T. STRONG INC.	2	2017–2017	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What T Strong, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	U fit Dental Implant System	2022
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Anchor DrillAnchor DriverDrill ExtensionFixture driver MiniFixture Driver RegFixture HandPiece Driver Hex for Digital GuideFixture Square Driver Hex for Digital GuideFlat DrillFull Stop Drill Surgical KitGuide Drill 9 more Guide Initial DrillParallal PinPilot DrillStep DrillTissue PunchTorque WrenchTorque Wrench for Square DriverTwist Drill1.2 Hex Driver for Wrench	2026
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	U fit Dental Implant System	2022

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 T Strong, Inc. as the applicant.

Decided	510(k)	Device	Device type
5 Jun 2014	K132956	U FIT DENTAL IMPLANT SYSTEM	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
T. STRONG INC.FDA reg. 3024859204	Gimhae-si Gyeongnam, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10086215). 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.