FDA.reportPublic FDA data

DTI IMPLANT SISTEMLERI

Primary DI
08680671492964
Brand
DTI IMPLANT SISTEMLERI
Company
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
Model
ABUTMENT SYSTEM
Catalog number
DTISCANPLUM
Device description
SCAN BODY ULTRA MINI LAB - 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
08680671492964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08680671492964086806714929648680671492964

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
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
08680671491073DTI IMPLANT SISTEMLERIANALOGDTI1BLAM2023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016100686Dental Implants Accesseories-Single UseCowellmedi Co.,LtdNDP2026-08-03
08800016108774Dental Implants Accesseories-ReusableCowellmedi Co.,LtdNDP2026-07-28
08800076476271T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-27
D7702682153RIGHT ANGLE SCREWDRIVER FORSWEDEN & MARTINA SPANDP2026-07-27
D7702698973DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702698983DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702750843INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
D7702750853INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
03701045246374KONTACTBIOTECH DENTALNDP2026-07-24
03701045246381KontactBIOTECH DENTALNDP2026-07-24
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14