FDA.reportPublic FDA data

Temporary Abutment

Primary DI
07290116153919
Brand
Temporary Abutment
Company
NORIS MEDICAL LTD
Model
NMCA5001
Catalog number
NMCA5001
Device description
Temporary Abutment, D4.3mm, H9.5mm, CP, Ti.
Published
2025-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116153919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116153919072901161539197290116153919

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+972737964477info@norismedical.com

Regulatory Flags#

DUNS number
649340106
Device count
1
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
07290116154787Dental DrillsNMSD7328NMSD73282026-07-09
07290116154794Diamond BurrsNM-D7204NM-D72042026-07-09
07290116155630PF-Pro ImplantNMAF3718NMAF37182026-06-25
07290116155647PF-Pro ImplantNMAF3720NMAF37202026-06-25
07290116155654PF-Pro ImplantNMAF3722NMAF37222026-06-25
07290116155661PF-Pro ImplantNMAF3725NMAF37252026-06-25
07290116155678PF-Pro ImplantNMCB3718NMCB37182026-06-25
07290116155685PF-Pro ImplantNMCB3720NMCB37202026-06-25
07290116155692PF-Pro ImplantNMCB3722NMCB37222026-06-25
07290116155708PF-Pro ImplantNMCB3725NMCB37252026-06-25
07290116155715PF-Pro ImplantNMCB4018NMCB40182026-06-25
07290116155722PF-Pro ImplantNMCB4020NMCB40202026-06-25
07290116155739PF-Pro ImplantNMCB4022NMCB40222026-06-25
07290116155746PF-Pro ImplantNMCB4025NMCB40252026-06-25
07290116155753Longy ImplantNMCL3718NMCL37182026-06-25
07290116155760Longy ImplantNMCL3720NMCL37202026-06-25
07290116155777Longy ImplantNMCL3722NMCL37222026-06-25
07290116155784Longy ImplantNMCL3725NMCL37252026-06-25
07290116155791Longy ImplantNMCL4018NMCL40182026-06-25
07290116155807Longy ImplantNMCL4020NMCL40202026-06-25

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Primary DI, Brand, Company table
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