Implant 3.75*8

GUDID 07290112280640

Implant

DENTACK IMPLANTS LTD

Screw endosteal dental implant, two-piece
Primary Device ID07290112280640
NIH Device Record Key4c86a9bc-dcb3-4583-83e4-0e9ec6adf9b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant 3.75*8
Version Model NumberEDI-3758
Company DUNS514897185
Company NameDENTACK 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97297660379
Emailinfo@pyramidion-is.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290112280640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290112280640]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-28
Device Publish Date2019-01-28

Devices Manufactured by DENTACK IMPLANTS LTD

07290112280831 - Expansion tool-screw 6.35+wrench short - Assy2019-12-20 Expansion tool-screw 6.35+wrench short - Assy
07290112280855 - Expansion tool EX-screw+wrench short - Assy2019-12-20 Expansion tool EX-screw+wrench short - Assy
07290112280664 - Implant 4.1*52019-03-11 Implant 4.1*5
07290112280671 - Straight MU Abutment2019-03-11 Straight MU Abutment
07290112280688 - Multi Unit Abutment for EX2019-03-11 Multi Unit Abutment for EX
07290112280695 - Straight MU Abutment2019-03-11 Straight MU Abutment
07290112280701 - Multi Unit Abutment for EX2019-03-11 Multi Unit Abutment for EX
07290112280718 - Straight MU Abutment2019-03-11 Straight MU Abutment

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