ESI ESIC50013R

GUDID D890ESIC50013R0

ESI Implant - Conical 5.0mmx13mm RBM Surface

SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.

Screw endosteal dental implant, two-piece
Primary Device IDD890ESIC50013R0
NIH Device Record Key924089cd-ddd3-4433-a04c-d6b732a9f5db
Commercial Distribution StatusIn Commercial Distribution
Brand NameESI
Version Model NumberESIC50013R
Catalog NumberESIC50013R
Company DUNS086863437
Company NameSPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com
Phone+13124407777
Emailinfo@spiraltech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD890ESIC50013R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-16

On-Brand Devices [ESI]

D980ESIC60013A0ESI Implant Conical 6.0mmx13mm SLA Surface
D890ESIC60015R0ESI Implant - Conical 6.0mmx15mm RBM Surface
D890ESIC60015A0ESI Implant Conical 6.0mmx15mm SLA Surface
D890ESIC60013R0ESI Implant - Conical 6.0mmx13mm RBM Surface
D890ESIC60011R0ESI Implant - Conical 6.0mmx11.5mm RBM Surface
D890ESIC60011A0ESI Implant Conical 6.0mmx11.5mm SLA Surface
D890ESIC60010R0ESI Implant - Conical 6.0mmx10mm RBM Surface
D890ESIC60010A0ESI Implant Conical 6.0mmx10mm SLA Surface
D890ESIC60008R0ESI Implant - Conical 6.0mmx8mm RBM Surface
D890ESIC60008A0ESI Implant Conical 6.0mmx8mm SLA Surface
D890ESIC50015R0ESI Implant - Conical 5.0mmx15mm RBM Surface
D890ESIC50015A0ESI Implant Conical 5.0mmx15mm SLA Surface
D890ESIC50013R0ESI Implant - Conical 5.0mmx13mm RBM Surface
D890ESIC50013A0ESI Implant Conical 5.0mmx13mm SLA Surface
D890ESIC50011R0ESI Implant - Conical 5.0x11.5mm RBM Surface
D890ESIC50011A0ESI Implant Conical 5.0mmx11.5mm SLA Surface
D890ESIC50010R0ESI Implant - Conical 5.0mmx10mm RBM Surface
D890ESIC50010A0ESI Implant Conical 5.0mmx10mm SLA Surface
D890ESIC50008R0ESI Implant - Conical 5.0mmx8mm RBM Surface
D890ESIC50008A0ESI Implant Conical 5.0mmx8mm SLA Surface
D890ESIC43015R0ESI Implant - Conical 4.3mmx15mm RBM Surface
D890ESIC43015A0ESI Implant Conical 4.3mmx15mm SLA Surface
D890ESIC43013R0ESI Implant - Conical 4.3mmx13mm RBM Surface
D890ESIC43013A0ESI Implant Conical 4.3mmx13mm SLA Surface
D890ESIC43011R0ESI Implant - Conical 4.3mmx11.5mm RBM Surface
D890ESIC43011A0ESI Implant Conical 4.3mmx11.5mm SLA Surface
D890ESIC43010R0ESI Implant - Conical 4.3mmx10mm RBM Surface
D890ESIC43010A0ESI Implant Conical 4.3mmx10mm SLA Surface
D890ESIC43008R0ESI Implant - Conical 4.3mmx8mm RBM Surface
D890ESIC43008A0ESI Implant Conical 4.3mmx8mm SLA Surface
D890ESIC35015R0ESI Implant - Conical 3.5mmx15mm RBM Surface
D890ESIC35015A0ESI Implant Conical 3.5mmx15mm SLA Surface
D890ESIC35013R0ESI Implant - Conical 3.5mmx13mm RBM Surface
D890ESIC35013A0ESI Implant Conical 3.5mmx13mm SLA Surface
D890ESIC35011R0ESI Implant - Conical 3.5mmx11.5mm RBM surface
D890ESIC35011A0ESI Implant Conical 3.5mmx11.5mm SLA Surface
D890ESIC35010R0ESI Implant - Conical 3.5mmx10mm RBM Surface
D890ESIC35010A0ESI Implant Conical 3.5mmx10mm SLA Surface
D890ESIC35008R0ESI Implant - Conical 3.5mmx8mm RBM Surface
D890ESIC35008A0ESI Implant Conical 3.5mmx8mm SLA Surface
D890ESIC30015R0ESI Implant - Conical 3.0mmx15mm RBM Surface
D890ESIC30015A0ESI Implant Conical 3.0mmx15mm SLA Surface
D890ESIC30013R0ESI Implant - Conical 3.0mmx13mm RBM Surface
D890ESIC30013A0ESI Implant Conical 3.0mmx13mm SLA Surface
D890ESIC30011R0ESI Implant - Conical 3.0mmx11.5mm RBM Surface
D890ESIC30011A0ESI Implant Conical 3.0mmx11.5mm SLA Surface
D890ESIC30010R0ESI Implant - Conical 3.0mmx10mm RBM Surface
D890ESIC30010A0ESI Implant Conical 3.0mmx10mm SLA Surface
D890ESI60015R0ESI Implant - Internal Hex - 6.0mmx15mm RBM Surface
D890ESI60015A0ESI Implant Hex 6.0mmx15mm SLA Surface
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