TRX-TP TRX-TP 2.8-11.5

GUDID 07290110722104

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, one-piece
Primary Device ID07290110722104
NIH Device Record Keyac98829f-9d68-4aa1-83bd-e8d3c52a5e6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRX-TP
Version Model NumberTRX-TP 2.8-11.5mm
Catalog NumberTRX-TP 2.8-11.5
Company DUNS600710917
Company NameHI-TEC IMPLANTS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110722104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-22

On-Brand Devices [TRX-TP]

07290110726690BALL-ATTACHMENT ABUTMENT
07290110726683BALL-ATTACHMENT ABUTMENT
07290110726355FIXED DETACHABLE ABUTMENT
07290110724627SCREW-IN ABUTMENT
07290110722135DENTAL IMPLANT
07290110722128DENTAL IMPLANT
07290110722111DENTAL IMPLANT
07290110722104DENTAL IMPLANT
07290110722098DENTAL IMPLANT
07290110722081DENTAL IMPLANT
07290110722074DENTAL IMPLANT
07290110722067DENTAL IMPLANT

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