XiVE® 25-2431

GUDID 07392532212123

XiVE® TG plus Implant D3.4/L9.5

Dentsply Implants Manufacturing GmbH

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece
Primary Device ID07392532212123
NIH Device Record Key64ce3013-76f3-421c-8048-72462d0c2e42
Commercial Distribution StatusIn Commercial Distribution
Brand NameXiVE®
Version Model Number32252431
Catalog Number25-2431
Company DUNS344038836
Company NameDentsply Implants Manufacturing GmbH
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsplysirona.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage, in the original packaging, at room temperature in a dry place away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS107392532212123 [Primary]
GS107392532212123 [Primary]
GS107392532212123 [Primary]
GS107392532212123 [Primary]
GS107392532212123 [Primary]
GS107392532212123 [Primary]
GS107392532212123 [Primary]
GS107392532212123 [Primary]

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

On-Brand Devices [XiVE®]

EFRI324643012MP Screw long
EFRI324632602MP Retention Sleeve long D5.5
EFRI324632502MP Retention Sleeve long D4.5
EFRI324632402MP Retention Sleeve long D3.8
EFRI324632302MP Retention Sleeve long D3.4
EFRI324631602MP Retention Sleeve short D5.5
EFRI324631502MP Retention Sleeve short D4.5
EFRI324631402MP Retention Sleeve short D3.8
EFRI324631302MP Retention Sleeve short D3.4
EFRI324631002MP Insert Head
EFRI324630432MP Abutment D3.8-5.5/GH3/A30
EFRI324630422MP Abutment D3.8-5.5/GH2/A30
EFRI324630332MP Abutment D3.4/GH3/A30
EFRI324630322MP Abutment D3.4/GH2/A30
EFRI324629452MP Abutment D3.8-5.5/GH5/A15
EFRI324629432MP Abutment D3.8-5.5/GH3/A15
EFRI324629422MP Abutment D3.8-5.5/GH2/A15
EFRI324629352MP Abutment D3.4/GH5/A15
EFRI324629332MP Abutment D3.4/GH3/A15
EFRI324629322MP Abutment D3.4/GH2/A15
EFRI322641062Conometric Abutment Ø3.8/3.0/15°/Ø4.5/I
EFRI322641052Conometric Abutment Ø3.8/2.0/15°/Ø4.5/I
EFRI322641042Conometric Abutment Ø3.8/1.0/15°/Ø4.5/I
EFRI322641032Conometric Abutment Ø3.8/3.0/0°/Ø4.5/I
EFRI322641022Conometric Abutment Ø3.8/2.0/0°/Ø4.5/I
EFRI322641012Conometric Abutment Ø3.8/1.0/0°/Ø4.5/I
EFRI322640062Conometric Abutment Ø3.4/3.0/15°/Ø4.5/I
EFRI322640052Conometric Abutment Ø3.4/2.0/15°/Ø4.5/I
EFRI322640042Conometric Abutment Ø3.4/1.0/15°/Ø4.5/I
EFRI322640032Conometric Abutment Ø3.4/3.0/0°/Ø4.5/I
EFRI322640022Conometric Abutment Ø3.4/2.0/0°/Ø4.5/I
EFRI322640012Conometric Abutment Ø3.4/1.0/0°/Ø4.5/I
EFRI322545202XiVE® TG AuroBase D3.4-4.5
EFRI322545102XiVE® TG Abutment angled D3.4-4.5/A15
EFRI322545002XiVE® TG Abutment straight D3.4-4.5/A0
EFRI322543002XiVE® TG Abutment Screw
EFRI322542462XiVE® TG Cast-to Waxing Sleeve D3.4-4.5
EFRI322542412XiVE® TG Titanium Bar Coping with Guide Pin
EFRI322542402XiVE® TG Gold Bar Coping with Guide Pin
EFRI322542002XiVE® TG Coping Screw
EFRI322624652XiVE® S plus Implant D5.5/L15
EFRI322624632XiVE® S plus Implant D5.5/L13
EFRI322624622XiVE® S plus Implant D5.5/L11
EFRI322624612XiVE® S plus Implant D5.5/L9.5
EFRI322624602XiVE® S plus Implant D5.5/L8
EFRI322624582XiVE® S plus Implant D4.5/L18
EFRI322624552XiVE® S plus Implant D4.5/L15
EFRI322624532XiVE® S plus Implant D4.5/L13
EFRI322624522XiVE® S plus Implant D4.5/L11
EFRI322624512XiVE® S plus Implant D4.5/L9.5

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