TRI ATL

GUDID 07290110727482

IMPLANT ANALOG

HI-TEC IMPLANTS LTD.

Dental implant analog
Primary Device ID07290110727482
NIH Device Record Keye616f99c-ada6-4d24-bcdc-97ea2468154b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRI
Version Model NumberATL
Catalog NumberATL
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
GS107290110727482 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-06-13

On-Brand Devices [TRI]

07290110727482IMPLANT ANALOG
07290110726928NYLON COPING
07290110722210DENTAL IMPLANT
07290110722203DENTAL IMPLANT
07290110722197DENTAL IMPLANT
07290110722180DENTAL IMPLANT

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