FDA.report

NA

Primary DI
07290108813432
Brand
NA
Company
NORIS MEDICAL LTD
Model
NM-H5504
Device description
Healing Cap, Diameter ø5.5, Height 4.0mm, Ti.
Published
2017-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290108813432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290108813432072901088134327290108813432

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+972737964477info@norismedical.com

Regulatory Flags

DUNS number
649340106
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 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
07290108811025Dental DrillNM-D1420NM-D14202025-11-11
07290108811032Dental DrillNM-D1428NM-D14282025-11-11
07290108811049Dental DrillNM-D1432NM-D14322025-11-11
07290108811056Dental DrillNM-D1436NM-D14362025-11-11
07290108811063Dental DrillNM-D1442NM-D14422025-11-11
07290108811070Dental DrillNM-D1452NM-D14522025-11-11
07290108811216Trephine DrillNM-D2030NM-D20302025-11-11
07290108811223Trephine DrillNM-D2040NM-D20402025-11-11
07290108811230Trephine DrillNM-D2050NM-D20502025-11-11
07290108811407Drill ExtenderNM-D3412NM-D34122025-11-11

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