TRX TRX 3.7-13

GUDID 07290110721954

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, one-piece
Primary Device ID07290110721954
NIH Device Record Key5d9348f7-0ad6-4502-9138-7cd17d59904d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRX
Version Model NumberTRX 3.7-13mm
Catalog NumberTRX 3.7-13
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
GS107290110721954 [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]

07290110727475IMPLANT ANALOG
07290110727369TRANSFER
07290110727352TRANSFER
07290110726911FIXATION SCREW
07290110726904CASTABLE PLASTIC SLEEVE
07290110726898CASTABLE PLASTIC SLEEVE
07290110726881CASTABLE PLASTIC SLEEVE
07290110726874CASTABLE PLASTIC SLEEVE
07290110726706BALL-ATTACHMENT ABUTMENT
07290110724610SCREW-IN ABUTMENT
07290110722999HEALING CAP
07290110721954DENTAL IMPLANT
07290110721947DENTAL IMPLANT
07290110721930DENTAL IMPLANT
07290110721923DENTAL IMPLANT

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