FDA.reportPublic FDA data

NA

Primary DI
ENTTMIC9S3D33001
Brand
NA
Company
NT-Trading GmbH & Co. KG
Model
MIC 9.S3D3.300
Catalog number
MIC 9.S3D3.300
Device description
Scanbody 3D-Guide®
Published
2023-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

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
ENTTMIC9S3D33001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497219619990xx@xx.xx

Regulatory Flags#

DUNS number
312800478
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ENTTTA9S3D3745N/ATA 9.S33D3.7452023-10-16
ENTTBEG9S3D32371NABEG 9.S3D3.237BEG 9.S3D3.2372023-07-21
ENTTBEG9S3D41001NABEG 9.S3D4.100BEG 9.S3D4.1002023-07-21
ENTTBEG9S3D45001NABEG 9.S3D4.500BEG 9.S3D4.5002023-07-21
ENTTBEG9S3D55001NABEG 9.S3D5.500BEG 9.S3D5.5002023-07-21
ENTTBIO9S3D30001NABIO 9.S3D3.000BIO 9.S3D3.0002023-07-21
ENTTBIO9S3D35001NABIO 9.S3D3.500BIO 9.S3D3.5002023-07-21
ENTTBIO9S3D45001NABIO 9.S3D4.500BIO 9.S3D4.5002023-07-21
ENTTBIO9S3D57001NABIO 9.S3D5.700BIO 9.S3D5.7002023-07-21
ENTTBRE9S3D35401NABRE 9.S3D3.540BRE 9.S3D3.5402023-07-21
ENTTCAM9S3D33001NACAM 9.S3D3.300CAM 9.S3D3.3002023-07-21
ENTTCAM9S3D38001NACAM 9.S3D3.800CAM 9.S3D3.8002023-07-21
ENTTCAM9S3D43001NACAM 9.S3D4.300CAM 9.S3D4.3002023-07-21
ENTTCAM9S3D50601NACAM 9.S3D5.060CAM 9.S3D5.0602023-07-21
ENTTCOL9S3D33001NACOL 9.S3D3.300COL 9.S3D3.3002023-07-21
ENTTCOL9S3D38431NACOL 9.S3D3.843COL 9.S3D3.8432023-07-21
ENTTCOL9S3D50001NACOL 9.S3D5.000COL 9.S3D5.0002023-07-21
ENTTE9S3D35001NAE 9.S3D3.500E 9.S3D3.5002023-07-21
ENTTE9S3D43001NAE 9.S3D4.300E 9.S3D4.3002023-07-21
ENTTE9S3D50001NAE 9.S3D5.000E 9.S3D5.0002023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14