FDA.report

Neodent

Primary DI
07899878025429
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
106.213
Catalog number
106.213
Device description
GM HEALING ABUTMENT
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
07899878025429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878025429078998780254297899878025429

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.

Device Sizes

TypeValueUnit
Height0.8Millimeter
Outer Diameter4.5Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room temperature

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags

DUNS number
906713888
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07899878068372Neodent116.305116.3052026-01-22
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07899878057024Neodent106.273106.2732023-07-13
07899878057031Neodent117.025117.0252023-07-13
07899878057048Neodent118.383118.3832023-07-13
07899878057055Neodent118.384118.3842023-07-13
07899878057062Neodent118.385118.3852023-07-13
07899878057079Neodent118.386118.3862023-07-13
07899878057109Neodent135.424-ET135.424-ET2023-07-13
07899878057116Neodent135.425-ET135.425-ET2023-07-13
07899878057123Neodent135.426-ET135.426-ET2023-07-13
07899878057130Neodent135.427-ET135.427-ET2023-07-13
07899878057147Neodent135.428-ET135.428-ET2023-07-13
07899878057154Neodent135.429-ET135.429-ET2023-07-13
07899878057161Neodent135.430-ET135.430-ET2023-07-13
07899878057178Neodent135.431-ET135.431-ET2023-07-13
07899878057185Neodent102.245102.2452023-07-13
07899878057192Neodent102.246102.2462023-07-13
07899878057208Neodent102.247102.2472023-07-13

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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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