FDA.reportPublic FDA data

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Primary DI
ENTTL9S3D33001
Brand
-
Company
NT-Trading GmbH & Co. KG
Model
L 9.S3D3.300
Catalog number
L 9.S3D3.300
Device description
Scanbody 3D-Guide®
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
ENTTL9S3D33001PrimaryHIBCC0

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ENTTTA9S3D3745N/ATA 9.S33D3.7452023-10-16
ENTTBEG5LA32371-BEG 5.LA3.237BEG 5.LA3.2372023-07-21
ENTTBEG5LA41001-BEG 5.LA4.100BEG 5.LA4.1002023-07-21
ENTTBEG5LA45001-BEG 5.LA4.500BEG 5.LA4.5002023-07-21
ENTTBEG5LA55001-BEG 5.LA5.500BEG 5.LA5.5002023-07-21
ENTTBEG9S3D32371-BEG 9.S3D3.237BEG 9.S3D3.2372023-07-21
ENTTBEG9S3D41001-BEG 9.S3D4.100BEG 9.S3D4.1002023-07-21
ENTTBEG9S3D45001-BEG 9.S3D4.500BEG 9.S3D4.5002023-07-21
ENTTBEG9S3D55001-BEG 9.S3D5.500BEG 9.S3D5.5002023-07-21
ENTTBEGTR0001321-BEG TR-00013.2BEG TR-00013.22023-07-21
ENTTBEGTR00024211-BEG TR-00024.2BEG TR-00024.22023-07-21
ENTTBEGTR0003451-BEG TR-00034.5BEG TR-00034.52023-07-21
ENTTBEGTR0004551-BEG TR-00045.5BEG TR-00045.52023-07-21
ENTTBIO5LA30001-BIO 5.LA3.000BIO 5.LA3.0002023-07-21
ENTTBIO5LA35001-BIO 5.LA3.500BIO 5.LA3.5002023-07-21
ENTTBIO5LA45001-BIO 5.LA4.500BIO 5.LA4.5002023-07-21
ENTTBIO5LA57001-BIO 5.LA5.700BIO 5.LA5.7002023-07-21
ENTTBIO9S3D30001-BIO 9.S3D3.000BIO 9.S3D3.0002023-07-21
ENTTBIO9S3D35001-BIO 9.S3D3.500BIO 9.S3D3.5002023-07-21
ENTTBIO9S3D45001-BIO 9.S3D4.500BIO 9.S3D4.5002023-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
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08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
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