Immediate Implant

GUDID D824IWC80060

Ø8.0mm x L6.0mm, Conical Connection, Wide Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824IWC80060
NIH Device Record Key1ffcdb80-84b5-417f-ad01-e92139d4448a
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmediate Implant
Version Model NumberIWC8006
Company DUNS080321629
Company NameSURGIKOR, LLC
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD824IWC80060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

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 Date2017-01-31

On-Brand Devices [Immediate Implant ]

D824IWC80100Ø8.0mm x L10.0mm, Conical Connection, Wide Platform
D824IWC80080Ø8.0mm x L8.0mm, Conical Connection, Wide Platform
D824IWC80060Ø8.0mm x L6.0mm, Conical Connection, Wide Platform
D824IWC70100Ø7.0mm x L10.0mm, Conical Connection, Wide Platform
D824IWC70080Ø7.0mm x L8.0mm, Conical Connection, Wide Platform
D824IWC70060Ø7.0mm x L6.0mm, Conical Connection, Wide Platform
D824IWC60160Ø6.0mm x L16.0mm, Conical Connection, Wide Platform
D824IWC60130Ø6.0mm x L13.0mm, Conical Connection, Wide Platform
D824IWC60110Ø6.0mm x L11.5mm, Conical Connection, Wide Platform
D824IWC60100Ø6.0mm x L10.0mm, Conical Connection, Wide Platform
D824IWC60080Ø6.0mm x L8.0mm, Conical Connection, Wide Platform
D824IWC60060Ø6.0mm x L6.0mm, Conical Connection, Wide Platform
D824IWC50160Ø5.0mm x L16.0mm, Conical Connection, Wide Platform
D824IWC50130Ø5.0mm x L13mm, Conical Connection, Wide Platform
D824IWC50110Ø5.0mm x L11.5mm, Conical Connection, Wide Platform
D824IWC50100Ø5.0mm x L10.0mm, Conical Connection, Wide Platform
D824IWC50080Ø5.0mm x L8.0mm, Conical Connection, Wide Platform
D824IWC50060Ø5.0mm x L6.0mm, Conical Connection, Wide Platform
D824IWC45160Ø4.5mm x L16.0mm, Conical Connection, Wide Platform
D824IWC45130Ø4.5mm x L13.0mm, Conical Connection, Wide Platform
D824IWC45110Ø4.5mm x L11.5mm, Conical Connection, Wide Platform
D824IWC45100Ø4.5mm x L10.0mm, Conical Connection, Wide Platform
D824IWC45080Ø4.5mm x L8.0mm, Conical Connection, Wide Platform
D824IWC45060Ø4.5mm x L6.0mm, Conical Connection, Wide Platform
D824IWC42160Ø4.2mm x L16.0mm, Conical Connection, Wide Platform
D824IWC42130Ø4.2mm x L13.0mm, Conical Connection, Wide Platform
D824IWC42110Ø4.2mm x L11.5mm, Conical Connection, Wide Platform
D824IWC42100Ø4.2mm x L10.0mm, Conical Connection, Wide Platform
D824IWC42080Ø4.2mm x L8.0mm, Conical Connection, Wide Platform
D824IRH80100Ø8.0mm x L10.0mm, Hex Connection, Regular Platform
D824IRH80080Ø8.0mm x L8.0mm, Hex Connection, Regular Platform
D824IRH80060Ø8.0mm x L6.0mm, Hex Connection, Regular Platform
D824IRH70100Ø7.0mm x L10.0mm, Hex Connection, Regular Platform
D824IRH70080Ø7.0mm x L8.0mm, Hex Connection, Regular Platform
D824IRH70060Ø7.0mm x L6.0mm, Hex Connection, Regular Platform
D824IRH60160Ø6.0mm x L16.0mm, Hex Connection, Regular Platform
D824IRH60130Ø6.0mm x L13.0mm, Hex Connection, Regular Platform
D824IRH60110Ø6.0mm x L11.5mm, Hex Connection, Regular Platform
D824IRH60100Ø6.0mm x L10.0mm, Hex Connection, Regular Platform
D824IRH60080Ø6.0mm x L8.0mm, Hex Connection, Regular Platform
D824IRH60060Ø6.0mm x L6.0mm, Hex Connection, Regular Platform
D824IRH50160Ø5.0mm x L16.0mm, Hex Connection, Regular Platform
D824IRH50130Ø5.0mm x L13.0mm, Hex Connection, Regular Platform
D824IRH50110Ø5.0mm x L11.5mm, Hex Connection, Regular Platform
D824IRH50100Ø5.0mm x L10.0mm, Hex Connection, Regular Platform
D824IRH50080Ø5.0mm x L8.0mm, Hex Connection, Regular Platform
D824IRH50060Ø5.0mm x L6.0mm, Hex Connection, Regular Platform
D824IRH45160Ø4.5mm x L16.0mm, Hex Connection, Regular Platform
D824IRH45130Ø4.5mm x L13.0mm, Hex Connection, Regular Platform
D824IRH45110Ø4.5mm x L11.5mm, Hex Connection, Regular Platform

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