FDA.reportPublic FDA data

N/A

Primary DI
ENTTTA9S3D3745
Brand
N/A
Company
NT-Trading GmbH & Co. KG
Model
TA 9.S33D3.745
Device description
Scanbody 3D-Guide®
Published
2023-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
ENTTTA9S3D3745PrimaryHIBCC0

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
Outer Diameter3.7Millimeter
Outer Diameter4Millimeter
Outer Diameter4.5Millimeter
Outer Diameter5Millimeter
Outer Diameter6Millimeter
Outer Diameter7Millimeter
Outer Diameter8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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
ENTTE9S3D60001NAE 9.S3D6.000E 9.S3D6.0002023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03