FDA.reportPublic FDA data

Neoss Implant System

Primary DI
05060440336539
Brand
Neoss Implant System
Company
Neoss AB
Model
31444
Catalog number
31444
Device description
Multi-Unit Replica - 5 pcs
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
05060440336539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440336539050604403365395060440336539

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
866 626-3677contact.usa@neoss.com

Regulatory Flags#

DUNS number
509583543
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060440335532Neoss Implant System64080640802023-02-13
05060440335549Neoss Implant System64081640812023-02-13
05060440335556Neoss Implant System64082640822023-02-13
05060440335563Neoss Implant System64083640832023-02-13
05060440334283Neoss Implant System64036640362020-11-27
05060440334290Neoss Implant System64037640372020-11-27
05060967630226Yomi One Implant System54001540012024-02-15
05060967630233Yomi One Implant System54002540022024-02-15
05060967630004Yomi One Implant System24008240082024-02-15
05060967630011Yomi One Implant System24009240092024-02-15
05060967630028Yomi One Implant System24010240102024-02-15
05060967630035Yomi One Implant System24011240112024-02-15
05060967630042Yomi One Implant System24012240122024-02-15
05060967630059Yomi One Implant System24014240142024-02-15
05060967630066Yomi One Implant System24015240152024-02-15
05060967630073Yomi One Implant System24016240162024-02-15
05060967630080Yomi One Implant System24017240172024-02-15
05060967630097Yomi One Implant System24018240182024-02-15
05060967630103Yomi One Implant System24020240202024-02-15
05060967630110Yomi One Implant System24021240212024-02-15

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Primary DI, Brand, Company table
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00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
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