FDA.reportPublic FDA data

Fixation screw

Primary DI
07290108818192
Brand
Fixation screw
Company
NORIS MEDICAL LTD
Model
NMBS1612
Catalog number
NMBS1612
Device description
Bone Screw D1.6 L12.0mm, Ti.
Published
2025-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290108818192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108818192072901088181927290108818192

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
Premarket exempt
true
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
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
07290116660141Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-11
07290114713245prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-06
07290114713252prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-06
00887919581703DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-28
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27