15 Shouldered Abutment - Wide Emergence

GUDID D824SW153WC0

"4.3mm x L7.5mm, w/ 3mm Shoulder Height, 15Deg. Angle,Wide Emergence, Conical Connection, Wide Platform"

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824SW153WC0
NIH Device Record Key45965399-2d3c-46a5-b9f8-18409b9cca79
Commercial Distribution StatusIn Commercial Distribution
Brand Name15 Shouldered Abutment - Wide Emergence
Version Model NumberSW153WC
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
HIBCCD824SW153WC0 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


[D824SW153WC0]

Moist Heat or Steam Sterilization


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 [15 Shouldered Abutment - Wide Emergence]

D824SW153WC0"4.3mm x L7.5mm, w/ 3mm Shoulder Height, 15Deg. Angle,Wide Emergence, Conical Connection, Wide P
D824SW152WC04.3mm x L7.5mm, w/ 2mm Shoulder Height,15Deg. Angle,Wide Emergence, ConicalConnection, Wide Plat

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