TRX-BA TRX-BA 3.3-10

GUDID 07290110721985

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, one-piece
Primary Device ID07290110721985
NIH Device Record Key6d9f9b27-8df5-42fe-a950-f0a3d99cdf35
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRX-BA
Version Model NumberTRX-BA 3.3-10mm
Catalog NumberTRX-BA 3.3-10
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
GS107290110721985 [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-BA]

07290110721992DENTAL IMPLANT
07290110721985DENTAL IMPLANT
07290110721978DENTAL IMPLANT
07290110721961DENTAL IMPLANT

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