TRI-N TC-N

GUDID 07290110726935

NYLON COPING

HI-TEC IMPLANTS LTD.

Dental implant system
Primary Device ID07290110726935
NIH Device Record Key9d83f8d5-f2ba-4a5c-bb45-9e38943594fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRI-N
Version Model NumberTC-N
Catalog NumberTC-N
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
GS107290110726935 [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 Date2017-06-12

On-Brand Devices [TRI-N]

07290110727499IMPLANT ANALOG
07290110726935NYLON COPING
07290110722173DENTAL IMPLANT
07290110722166DENTAL IMPLANT
07290110722159DENTAL IMPLANT
07290110722142DENTAL IMPLANT

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