FDA.reportPublic FDA data

Ufit Dental Implant

Primary DI
08806395200689
Brand
Ufit Dental Implant
Company
T Strong Co., Ltd.
Model
50115T
Catalog number
NT2 50115T
Device description
Titanium dental endosseous root-form implant fixture. Single use, sterile (gamma irradiation). For use in dental implant procedures.
Published
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132956000U FIT DENTAL IMPLANT SYSTEMT Strong, Inc.2014-06-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806395200689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806395200689088063952006898806395200689

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
+82553421771Info.ufit@ufitimplant.com

Regulatory Flags#

DUNS number
688692008
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806395200535Ufit Dental Implant4007TNT2 4007T2026-05-28
08806395200542Ufit Dental Implant40085TNT2 40085T2026-05-28
08806395200559Ufit Dental Implant4010TNT2 4010T2026-05-28
08806395200566Ufit Dental Implant40115TNT2 40115T2026-05-28
08806395200573Ufit Dental Implant4013TNT2 4013T2026-05-28
08806395200580Ufit Dental Implant4015TNT2 4015T2026-05-28
08806395200597Ufit Dental Implant4507TNT2 4507T2026-05-28
08806395200603Ufit Dental Implant45085TNT2 45085T2026-05-28
08806395200610Ufit Dental Implant4510TNT2 4510T2026-05-28
08806395200627Ufit Dental Implant45115TNT2 45115T2026-05-28
08806395200634Ufit Dental Implant4513TNT2 4513T2026-05-28
08806395200641Ufit Dental Implant4515TNT2 4515T2026-05-28
08806395200658Ufit Dental Implant5007TNT2 5007T2026-05-28
08806395200665Ufit Dental Implant50085TNT2 50085T2026-05-28
08806395200672Ufit Dental Implant5010TNT2 5010T2026-05-28
08806395200696Ufit Dental Implant5013TNT2 5013T2026-05-28
08806395200702Ufit Dental Implant5015TNT2 5015T2026-05-28
08806395200719Ufit Dental Implant5507TNT2 5507T2026-05-28
08806395200726Ufit Dental Implant55085TNT2 55085T2026-05-28
08806395200733Ufit Dental Implant5510TNT2 5510T2026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200832Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28