FDA.reportPublic FDA data

Tuff Implant

Primary DI
07290116152288
Brand
Tuff Implant
Company
NORIS MEDICAL LTD
Model
NM3F4218
Catalog number
NM3F4218
Device description
Tuff, D4.2, L18, 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
07290116152288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116152288072901161522887290116152288

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
07290108814750DriverNM-X1006NM-X10062025-12-03
07290108814767DriverNM-X1007NM-X10072025-12-03
07290108814774Motor Mount driverNM-X1008NM-X10082025-12-03
07290108814781Motor Mount driverNM-X1009NM-X10092025-12-03
07290108814279AnalogNM-T6004NM-T60042025-11-13
07290108814286AnalogNM-T6005NM-T60052025-11-13
07290108814293AnalogNM-T6124NM-T61242025-11-13
07290108814309AnalogNM-T6202NM-T62022025-11-13
07290108814323TransferNM-T7102NM-T71022025-11-13
07290108814361AnalogNM-T7151NM-T71512025-11-13
07290108811889Dental DrillNM-D7428NM-D74282025-11-12
07290108811896Dental DrillNM-D7432NM-D74322025-11-12
07290108811902Dental DrillNM-D7436NM-D74362025-11-12
07290108814088TransferNM-T3409NM-T34092025-11-12
07290108814095TransferNM-T3413NM-T34132025-11-12
07290108814101TransferNM-T3507NM-T35072025-11-12
07290108814118TransferNM-T3511NM-T35112025-11-12
07290108814125TransferNM-T3601NM-T36012025-11-12
07290108814132TransferNM-T3802NM-T38022025-11-12
07290108814149TransferNM-T3803NM-T38032025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031742124Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742131Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742148Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742155Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742162Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742179Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742186Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742193Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742209Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742216Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742223Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742230Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742247Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742254Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742407Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742414Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742421Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742438Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742445Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742452Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742469Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742476Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742483Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742490Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742506Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742513Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742520Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742537Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742612Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742629Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06