TAPERED SELF THREAD GTI-8SR

GUDID 07290110720117

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece
Primary Device ID07290110720117
NIH Device Record Keye87e9021-a389-42c5-ac66-2254a523a0ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTAPERED SELF THREAD
Version Model NumberGTI-8mmSR
Catalog NumberGTI-8SR
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
GS107290110720117 [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 Date2017-05-22

On-Brand Devices [TAPERED SELF THREAD]

07290110720209DENTAL IMPLANT
07290110720193DENTAL IMPLANT
07290110720186DENTAL IMPLANT
07290110720179DENTAL IMPLANT
07290110720162DENTAL IMPLANT
07290110720155DENTAL IMPLANT
07290110720148DENTAL IMPLANT
07290110720131DENTAL IMPLANT
07290110720124DENTAL IMPLANT
07290110720117DENTAL IMPLANT
07290110720100DENTAL IMPLANT
07290110720094DENTAL IMPLANT
07290110720087DENTAL IMPLANT
07290110720070DENTAL IMPLANT
07290110720063SLT-8mmSR
07290110720056NTI-16mmSR
07290110720049NTI-13mmSR
07290110720032NTI-11.5mmSR
07290110720025NTI-10mmSR
07290110720018NTI-8mmSR

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