TRI-OR TRI-OR 1.3-6

GUDID 07290110722227

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Transmandibular implant
Primary Device ID07290110722227
NIH Device Record Key695709b4-c77f-430c-83b4-dcf210f1baa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRI-OR
Version Model NumberTRI-OR 1.3-6mm
Catalog NumberTRI-OR 1.3-6
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
GS107290110722227 [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 Date2017-06-07

On-Brand Devices [TRI-OR]

07290110722258DENTAL IMPLANT
07290110722241DENTAL IMPLANT
07290110722234DENTAL IMPLANT
07290110722227DENTAL IMPLANT

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