FDA.reportPublic FDA data

DTI IMPLANT SISTEMLERI

Primary DI
08680671493015
Brand
DTI IMPLANT SISTEMLERI
Company
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
Model
ABUTMENT SYSTEM
Catalog number
DTISCANPS
Device description
SCAN BODY STANDARD - IMPLANT
Published
2023-01-24
Public version status
Update
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
08680671493015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08680671493015086806714930158680671493015

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use 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
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
08680671491073DTI IMPLANT SISTEMLERIANALOGDTI1BLAM2023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14