FDA.reportPublic FDA data

Tuff Implant

Primary DI
07290116152356
Brand
Tuff Implant
Company
NORIS MEDICAL LTD
Model
NM3F5011
Catalog number
NM3F5011
Device description
Tuff, D5.0, L11.5, Int. Hex Ti. Implant
Published
2025-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116152356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116152356072901161523567290116152356

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

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
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230374ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230398ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26