TRX X-BBA

GUDID 07290110726706

BALL-ATTACHMENT ABUTMENT

HI-TEC IMPLANTS LTD.

Dental implant system
Primary Device ID07290110726706
NIH Device Record Key66391b4e-76b2-4482-a95d-2caf70448d10
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRX
Version Model NumberX-BBA
Catalog NumberX-BBA
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110726706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-06
Device Publish Date2017-06-12

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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