FDA.reportPublic FDA data

Straumann TLX Implant System

Primary DI
07630031746214
Brand
Straumann TLX Implant System
Company
Institut Straumann AG
Model
Screws
Catalog number
036.3110
Device description
NT/RT/WT Basal Screw, TAN
Published
2020-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200586000Straumann TLX Implant SystemInstitut Straumann AG2020-08-20DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031746214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031746214076300317462147630031746214

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031782298Straumann Modular CassetteStorage Systems / Cassettes041.8192026-05-07
07630031770936Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53442026-04-08
07630031770943Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53452026-04-08
07630031770950Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53462026-04-08
07630031770967Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53552026-04-08
07630031770974Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53562026-04-08
07630031770981Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53572026-04-08
07630031770998Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53582026-04-08
07630031771001Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53592026-04-08
07630031771018Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53602026-04-08
07630031771025Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53612026-04-08
07630031771032Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53622026-04-08
07630031771049Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53632026-04-08
07630031771056Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53642026-04-08
07630031771063Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53652026-04-08
07630031771070Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53662026-04-08
07630031771087Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53672026-04-08
07630031771094Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53682026-04-08
07630031771100Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53692026-04-08
07630031771117Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53702026-04-08

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Primary DI, Brand, Company table
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