FDA.reportPublic FDA data

Tuff Implant

Primary DI
07290116152431
Brand
Tuff Implant
Company
NORIS MEDICAL LTD
Model
NM3F6016
Catalog number
NM3F6016
Device description
Tuff, D6.0, L16, Int. Hex Ti. Implant
Published
2025-04-09
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
07290116152431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116152431072901161524317290116152431

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
07290108810639Plastic Castable AbutmentNM-C2003NM-C20032026-08-18
07290108810646Plastic Castable AbutmentNM-C2004NM-C20042026-08-18
07290108810653Plastic Castable AbutmentNM-C2005NM-C20052026-08-18
07290108810684Plastic Castable AbutmentNM-C3001NM-C30012026-08-18
07290108810691Plastic Castable AbutmentNM-C3002NM-C30022026-08-18
07290108810707Plastic Castable AbutmentNM-C3003NM-C30032026-08-18
07290108810714Plastic Castable AbutmentNM-C3201NM-C32012026-08-18
07290108810721Plastic Castable AbutmentNM-C3202NM-C32022026-08-18
07290108810738Plastic Castable AbutmentNM-C3203NM-C32032026-08-18
07290108810745Plastic Castable AbutmentNM-C4001NM-C40012026-08-18
07290108810752Plastic Castable AbutmentNM-C4002NM-C40022026-08-18
07290108810769Plastic Castable AbutmentNM-C4003NM-C40032026-08-18
07290108810868Plastic Castable AbutmentNM-C7120NM-C71202026-08-18
07290108816785Scanning dental implant abutmentNM-C9007NM-C90072026-08-18
07290108817171Scanning dental implant abutmentNM-C9013NM-C90132026-08-18
07290108817300Scanning dental implant abutmentNM-C9207NM-C92072026-08-18
07290108817324Scanning dental implant abutmentNM-C9213NM-C92132026-08-18
07290108819120Dental DrillNMCD3018NMCD30182026-08-18
07290108819137Dental DrillNMCD3020NMCD30202026-08-18
07290108819144Dental DrillNMCD3025NMCD30252026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
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07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
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07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16