FDA.reportPublic FDA data

Countersink Drill

Primary DI
07290108819502
Brand
Countersink Drill
Company
NORIS MEDICAL LTD
Model
NMCD1034
Catalog number
NMCD1034
Device description
Drill, Countersink, D3.8-4.2mm, DLC, SS.
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
07290108819502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108819502072901088195027290108819502

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. 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
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
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328964Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328971Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328988Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328995Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329008Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329015Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329022Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329039Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329046Profile Drill,BLT,Φ3.3mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329060Profile Drill,BLT,Φ4.1mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329084Profile Drill,BLT,Φ4.8mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18