Straumann Extraoral Implant System 048.525

GUDID 07630031724823

EO conical abutment 15° short, Neck lenght 3.5 mm, Titanium

Institut Straumann AG

Dental implant suprastructure, permanent, preformed
Primary Device ID07630031724823
NIH Device Record Keyee85dc01-17a1-49d2-a75e-1bd59878b426
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraumann Extraoral Implant System
Version Model NumberEO
Catalog Number048.525
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree
Length3.5 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031724823 [Primary]

FDA Product Code

KCZPROSTHESIS, BREAST, EXTERNAL, USED WITH ADHESIVE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


[07630031724823]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-02

On-Brand Devices [Straumann Extraoral Implant System]

07630031722409EO Healing cap, D 3.5mm, L 3.8mm, Ti
07630031724878EO Paralleling guide, Ø 3.5mm, L 15.0mm, stainless steel
07630031724830EO conical abutment 15° short, Neck lenght 5.5 mm, Titanium
07630031724823EO conical abutment 15° short, Neck lenght 3.5 mm, Titanium
07630031723703EO Gold cap 15°, Ø 4.8mm, L 5.5mm, ceramicon
07630031721433EO implant iserting device, Length 10.0 mm, Stainless steel, PEEK
07630031720016EO Stop drill for implant 042.362S Ø 2.8mm, L 24mm, stainless steel
07630031720009EO Stop drill for implant 042.360S Ø 2.8mm, L 22.5mm, stainless steel
07630031719997EO Profile drill for implant 042.367S Ø 2.8mm, L 25mm, stainless steel
07630031719980EO Profile drill for implant 042.365S Ø 2.8mm, L 25mm, stainless steel
07630031718211EO implant Ø 3.3 / 5.5 mm, Insertion depth 4.0 mm, Titanium
07630031718204EO implant Ø 3.3 / 5.5 mm, Insertion depth 2.5 mm, Titanium
07630031718198EO implant Ø 3.3 / 3.5 mm, Insertion depth 5.0 mm, Titanium
07630031718181EO implant Ø 3.3 / 3.5 mm, Insertion depth 3.5 mm, Titanium

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.