FDA.reportPublic FDA data

DTI IMPLANT SISTEMLERI

Primary DI
08680671491516
Brand
DTI IMPLANT SISTEMLERI
Company
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
Model
SURGICAL KIT
Catalog number
DTIDDREX
Device description
DRILL EXTENSION
Published
2023-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08680671491516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08680671491516086806714915168680671491516

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
505271005
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08680671491486DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTIESCANL2023-01-24
08680671491493DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTIESCANS2023-01-24
08680671492681DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTIMSCP2023-01-24
08680671492780DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTITSCANS2023-01-24
08680671492797DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTITSCANL2023-01-24
08680671492964DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTISCANPLUM2023-01-24
08680671492971DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTISCANPLM2023-01-24
08680671492988DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTISCANPLS2023-01-24
08680671492995DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTISCANPUM2023-01-24
08680671493008DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTISCANPM2023-01-24
08680671493015DTI IMPLANT SISTEMLERIABUTMENT SYSTEMDTISCANPS2023-01-24
08680671492049DTI IMPLANT SISTEMLERISURGICAL KITDTIRACHT2023-01-24
08680671490892DTI IMPLANT SISTEMLERIImplant TransferDTI1ITI4011M 2023-01-25
08680671490908DTI IMPLANT SISTEMLERIImplant TransferDTI1ITI4014M2023-01-25
08680671490915DTI IMPLANT SISTEMLERIImplant TransferDTI1ITI4011S2023-01-25
08680671490922DTI IMPLANT SISTEMLERIImplant TransferDTI1ITI4014S2023-01-25
08680671490939DTI IMPLANT SISTEMLERIImplant TransferDTI1ITI5011S2023-01-25
08680671490946DTI IMPLANT SISTEMLERIImplant TransferDTI1ITI5014S2023-01-25
08680671490953DTI IMPLANT SISTEMLERIANALOGDTI1ILAM2023-01-25
08680671490960DTI IMPLANT SISTEMLERIANALOGDTI1ILAS2023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09