TLX SRAs And TLX Gold Abutments 037.0411S

GUDID 07630031755148

NT Screw-retained Abutment, angled 30°, AH 3.5mm, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID07630031755148
NIH Device Record Keyfa59c19d-8fc0-41ac-bf04-4728e47f456a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLX SRAs And TLX Gold Abutments
Version Model NumberFinal Abutments
Catalog Number037.0411S
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(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

Angle30 degree
Height3.5 Millimeter
Angle30 degree
Height3.5 Millimeter
Angle30 degree
Height3.5 Millimeter
Angle30 degree
Height3.5 Millimeter
Angle30 degree
Height3.5 Millimeter
Angle30 degree
Height3.5 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031755148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, implant, dental, endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-18
Device Publish Date2022-05-10

On-Brand Devices [TLX SRAs And TLX Gold Abutments]

07630031755209WT Gold Abutment, bridge, H 4mm, Ceramicor®/POM
07630031755193RT Gold Abutment, bridge, H 3.6mm, Ceramicor®/POM
07630031755186NT Gold Abutment, bridge, H 3mm, Ceramicor®/POM
07630031755179WT Gold Abutment, crown, H 4mm, Ceramicor®/POM
07630031755162RT Gold Abutment, crown, H 3.6mm, Ceramicor®/POM
07630031755155NT Gold Abutment, crown, H 3mm, Ceramicor®/POM
07630031755148NT Screw-retained Abutment, angled 30°, AH 3.5mm, TAN
07630031755131NT Screw-retained Abutment, angled 17°, AH 3.5mm, TAN

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