MULTI-UNIT SCREW, HEX

GUDID D824SCCHAD0

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824SCCHAD0
NIH Device Record Key315e954e-6af2-4d9f-aaf8-33a115845e1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMULTI-UNIT SCREW, HEX
Version Model NumberSCCHad
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
HIBCCD824SCCHAD0 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-21
Device Publish Date2019-08-13

Devices Manufactured by SURGIKOR, LLC

D824IRH45070 - Immediate Implant 2024-09-24 Ø4.5mm x L7.0mm, Regular Connection, Hex Platform
D824IWC70110 - Immediate Implant 2022-07-28 Ø7.0mm x L11.5mm, Conical Connection, Wide Platform
D824IWC70130 - Immediate Implant 2022-07-28 Ø7.0mm x L13.0mm, Conical Connection, Wide Platform
D824PIWC70112 - Immediate Implant Pack2022-07-27 Ø7.0mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount
D824PIWC70130 - Immediate Implant Pack2022-07-27 Ø7.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
D824SK15017S0 - Titanium Base for Cad / Cam2020-08-04 Hex Connection, Regular Platform, Non Indexed
D824SK15041S0 - Titanium Base for Cad / Cam2020-08-04 Conical Connection, Regular Platform, Non Indexed
D824SK15042S0 - Titanium Base for Cad / Cam2020-08-04 Conical Connection, Wide Platform, Non Indexed

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