TRX-OP OP-TC

GUDID 07290110726942

NYLON COPING

HI-TEC IMPLANTS LTD.

Dental implant system
Primary Device ID07290110726942
NIH Device Record Key6135bead-721d-4e63-bf6b-a665394e953c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRX-OP
Version Model NumberOP-TC
Catalog NumberOP-TC
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
GS107290110726942 [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 [TRX-OP]

07290110727512IMPLANT ANALOG
07290110727505IMPLANT ANALOG
07290110726973NYLON COPING
07290110726966NYLON COPING
07290110726959NYLON COPING
07290110726942NYLON COPING
07290110723019HEALING CAP
07290110723002HEALING CAP
07290110722050DENTAL IMPLANT
07290110722043DENTAL IMPLANT
07290110722036DENTAL IMPLANT
07290110722029DENTAL IMPLANT
07290110722012DENTAL IMPLANT
07290110722005DENTAL IMPLANT

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