Device
Titanium dental endosseous root-form implant fixture. Single use, sterile (gamma irradiation). For use in dental implant procedures.
Manufacturer
T Strong Co., Ltd.
T Strong Co., Ltd.
Model: 5010MT
Catalog: GT2 5010MT
DI: 08806395202430
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Titanium dental endosseous root-form implant fixture. Single use, sterile (gamma irradiation). For use in dental implant procedures.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
37396c39-335b-428b-899c-ad4469a6c873
Distribution Status:
In Commercial Distribution
DUNS Number:
688692008
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08806395202430
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55849
Name: Screw endosteal dental implant, two-piece
Definition:
A 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.
FDA Product Codes
DZE
Implant, Endosseous, Root-Form
Premarket Submissions
Submission Number:
K132956
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Millimeter
Device Size - Size - @attributes - Value:
5.0
Device Size - Size Type:
Outer Diameter