Abutment regular screw

GUDID D824SCHSH0

Abutment short screw for Hex Connection

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824SCHSH0
NIH Device Record Keya9cdb1f0-3e6f-4fec-8533-d39502ed6b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutment regular screw
Version Model NumberSCHsh
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
HIBCCD824SCHSH0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


[D824SCHSH0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-06

On-Brand Devices [Abutment regular screw]

D824SCHSH0Abutment short screw for Hex Connection
D824SCHR0Abutment regular screw for Connical Connection M-2
D824SCCWR0Abutment regular screw for Connical connection M-2
D824SCCRR0Abutment regular screw for Connical connection M1.6
D824SCCNR0Abutment regular screw for Connical connection M1.4

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