Straumann TLX Implant System 035.0312S

GUDID 07630031751195

TLX S Implant, Ø 4.0mm RT, SLA® 12mm, Roxolid®

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031751195
NIH Device Record Key06085da1-d191-49de-9edc-f71d7f231251
Commercial Distribution Discontinuation2024-09-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameStraumann TLX Implant System
Version Model NumberSLA Roxolid TL
Catalog Number035.0312S
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 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(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 Dimensions

Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031751195 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-16
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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