Straumann TLX Implant System 036.3111

GUDID 07630031746221

NT/RT/WT Basal Screw AS, TAN

Institut Straumann AG

Dental prosthesis/implant abutment screw
Primary Device ID07630031746221
NIH Device Record Keyadb46343-e788-4646-96cf-150d4a6601cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraumann TLX Implant System
Version Model NumberScrews
Catalog Number036.3111
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031746221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

[07630031746221]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-21
Device Publish Date2020-11-06

On-Brand Devices [Straumann TLX Implant System]

07630031747259NT/RT/WT SRBB Basal Screw AS, TAN, 036.3111
07630031747242NT/RT/WT SRBB Basal Screw, TAN, 036.3110
07630031746221NT/RT/WT Basal Screw AS, TAN
07630031746214NT/RT/WT Basal Screw, TAN
07630031751645TLX S Implant, Ø 4.0mm RT, SLActive® 18mm, Roxolid®
07630031751638TLX S Implant, Ø 4.0mm RT, SLActive® 16mm, Roxolid®
07630031751621TLX S Implant, Ø 4.0mm RT, SLActive® 14mm, Roxolid®
07630031751614TLX S Implant, Ø 4.0mm RT, SLActive® 12mm, Roxolid®
07630031751607TLX S Implant, Ø 4.0mm RT, SLActive® 10mm, Roxolid®
07630031751591TLX S Implant, Ø 4.0mm RT, SLActive® 8mm, Roxolid®
07630031751584TLX S Implant, Ø 4.0mm RT, SLActive® 6mm, Roxolid®
07630031751577TLX S Implant, Ø 4.0mm NT, SLActive® 18mm, Roxolid®
07630031751560TLX S Implant, Ø 4.0mm NT, SLActive® 16mm, Roxolid®
07630031751553TLX S Implant, Ø 4.0mm NT, SLActive® 14mm, Roxolid®
07630031751546TLX S Implant, Ø 4.0mm NT, SLActive® 12mm, Roxolid®
07630031751539TLX S Implant, Ø 4.0mm NT, SLActive® 10mm, Roxolid®
07630031751522TLX S Implant, Ø 4.0mm NT, SLActive® 8mm, Roxolid®
07630031751515TLX S Implant, Ø 4.0mm NT, SLActive® 6mm, Roxolid®
07630031751508TLX S Implant, Ø 5.0mm WT, SLActive® 18mm, Roxolid®
07630031751492TLX S Implant, Ø 5.0mm WT, SLActive® 16mm, Roxolid®
07630031751485TLX S Implant, Ø 5.0mm WT, SLActive® 14mm, Roxolid®
07630031751478TLX S Implant, Ø 5.0mm WT, SLActive® 12mm, Roxolid®
07630031751461TLX S Implant, Ø 5.0mm WT, SLActive® 10mm, Roxolid®
07630031751454TLX S Implant, Ø 5.0mm WT, SLActive® 8mm, Roxolid®
07630031751447TLX S Implant, Ø 5.0mm WT, SLActive® 6mm, Roxolid®
07630031751430TLX S Implant, Ø 5.0mm WT, SLA® 18mm, Roxolid®
07630031751423TLX S Implant, Ø 5.0mm WT, SLA® 16mm, Roxolid®
07630031751416TLX S Implant, Ø 5.0mm WT, SLA® 14mm, Roxolid®
07630031751409TLX S Implant, Ø 5.0mm WT, SLA® 12mm, Roxolid®
07630031751393TLX S Implant, Ø 5.0mm WT, SLA® 10mm, Roxolid®
07630031751386TLX S Implant, Ø 5.0mm WT, SLA® 8mm, Roxolid®
07630031751379TLX S Implant, Ø 5.0mm WT, SLA® 6mm, Roxolid®
07630031751225TLX S Implant, Ø 4.0mm RT, SLA® 18mm, Roxolid®
07630031751218TLX S Implant, Ø 4.0mm RT, SLA® 16mm, Roxolid®
07630031751201TLX S Implant, Ø 4.0mm RT, SLA® 14mm, Roxolid®
07630031751195TLX S Implant, Ø 4.0mm RT, SLA® 12mm, Roxolid®
07630031751188TLX S Implant, Ø 4.0mm RT, SLA® 10mm, Roxolid®
07630031751171TLX S Implant, Ø 4.0mm RT, SLA® 8mm, Roxolid®
07630031751164TLX S Implant, Ø 4.0mm RT, SLA® 6mm, Roxolid®
07630031751157TLX S Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid®
07630031751140TLX S Implant, Ø 4.0mm NT, SLA® 16mm, Roxolid®
07630031751133TLX S Implant, Ø 4.0mm NT, SLA® 14mm, Roxolid®
07630031751126TLX S Implant, Ø 4.0mm NT, SLA® 12mm, Roxolid®
07630031751119TLX S Implant, Ø 4.0mm NT, SLA® 10mm, Roxolid®
07630031751102TLX S Implant, Ø 4.0mm NT, SLA® 8mm, Roxolid®
07630031751096TLX S Implant, Ø 4.0mm NT, SLA® 6mm, Roxolid®
07630031743176TLX SP Implant, Ø 5.0mm WT, SLActive® 18mm, Roxolid®
07630031743169TLX SP Implant, Ø 5.0mm WT, SLActive® 16mm, Roxolid®
07630031743152TLX SP Implant, Ø 5.0mm WT, SLActive® 14mm, Roxolid®
07630031743145TLX SP Implant, Ø 5.0mm WT, SLActive® 12mm, Roxolid®
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