Titanium Casting Sleeve for Straight Adaptor

GUDID D824TSADPWC0

Ø4.5mm x L12.0mm, Conical Connection, Wide Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824TSADPWC0
NIH Device Record Keyc454adbb-9d08-4baf-8c41-de1b7353362b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium Casting Sleeve for Straight Adaptor
Version Model NumberTSADPWC
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
HIBCCD824TSADPWC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

Moist Heat or Steam Sterilization


[D824TSADPWC0]

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 [Titanium Casting Sleeve for Straight Adaptor]

D824TSADPWC0Ø4.5mm x L12.0mm, Conical Connection, Wide Platform
D824TSADPRH0Ø4.5mm x L12.0mm, Hex Connection, Regular Platform
D824TSADPRC0Ø4.5mm x L12.0mm, Conical Connection, Regular Platform
D824TSADPNC0Ø4.5mm x L12.0mm, Conical Connection, Narrow Platform

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