ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DEN 040.197

GUDID 07630031717276

Bar set, plastic, 2x048.601, 2x048.124, 2x048.227, 2x048.350

Institut Straumann AG

Dental implant prosthetic teeth bar
Primary Device ID07630031717276
NIH Device Record Key2b37127c-630e-43c0-abe1-3a837e11907e
Commercial Distribution StatusIn Commercial Distribution
Brand NameABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DEN
Version Model Number1
Catalog Number040.197
Company DUNS483599259
Company NameInstitut Straumann AG
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 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+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
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
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

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Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031717276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


[07630031717276]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DEN]

07630031717276Bar set, plastic, 2x048.601, 2x048.124, 2x048.227, 2x048.350
07630031717269Bar set, titanium, 2x048.601, 2x048.124, 2x048.214, 2x048.350

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