FDA.reportPublic FDA data

Fixation screw

Primary DI
07290116150604
Brand
Fixation screw
Company
NORIS MEDICAL LTD
Model
NM-X2910
Catalog number
NM-X2910
Device description
EZguide Oclusal Fixation Screw, D5.0, L10, SS
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07290116150604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116150604072901161506047290116150604

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation drilling template stabilization boltA threaded bolt with a proximal flange intended to be used with a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation), to temporarily fix the template to a dental implant, immediately following implant introduction. It is intended to pass through the guide hole of the template and screw into the implant (much like a dental abutment); the proximal flange allows the template to be secured. This is a reusable 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07