Fixation Implant

GUDID D824FRC39130

Ø3.9mm x L13.0mm, Conical Connection, Regular Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece
Primary Device IDD824FRC39130
NIH Device Record Key176fcb4d-53eb-442e-9292-eed05f73b5ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation Implant
Version Model NumberFRC3913
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD824FRC39130 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-16
Device Publish Date2019-08-08

On-Brand Devices [Fixation Implant]

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D824FWC50110Ø5.0mm x L11.5mm, Conical Connection, Wide Platform
D824FWC50100Ø5.0mm x L10.0mm, Conical Connection, Wide Platform
D824FWC50080Ø5.0mm x L8.5 mm, Conical Connection, Wide Platform
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D824FWC43150Ø4.3mm x L15.0mm, Conical Connection, Wide Platform
D824FWC43130Ø4.3mm x L13.0mm, Conical Connection, Wide Platform
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D824FRC35150Ø3.5mm x L15.0mm, Conical Connection, Regular Platform
D824FRC35130Ø3.5mm x L13.0mm, Conical Connection, Regular Platform
D824FRC35110Ø3.5mm x L11.5mm, Conical Connection, Regular Platform
D824FRC35100Ø3.5mm x L10.0mm, Conical Connection, Regular Platform
D824FRC35080Ø3.5mm x L8.5mm, Conical Connection, Regular Platform
D824FNC30150Ø3.0mm x L15.0mm, Conical Connection, Narrow Platform
D824FNC30130Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform
D824FNC30110Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform
D824FNC30100Ø3.0mm x L10mm, Conical Connection, Narrow Platform
D824FRC39180Ø3.9mm x L18.0mm, Conical Connection, Regular Platform
D824FRC39150Ø3.9mm x L15.0mm, Conical Connection, Regular Platform
D824FRC39130Ø3.9mm x L13.0mm, Conical Connection, Regular Platform
D824FRC39110Ø3.9mm x L11.5mm, Conical Connection, Regular Platform
D824FRC39100Ø3.9mm x L10.0mm, Conical Connection, Regular Platform
D824FRC39080Ø3.9mm x L8.5mm, Conical Connection, Regular Platform
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