FDA.report

Neoss Implant System

Primary DI
05060440332302
Brand
Neoss Implant System
Company
Neoss Ltd
Model
31166
Catalog number
31166
Device description
Protection Replica - 1 pc
Published
2015-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060440332302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060440332302050604403323025060440332302

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
999-999-9999contact.usa@neoss.com

Regulatory Flags

DUNS number
216693627
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
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
05060440333774Neoss Implant SystemIndividual Abutment, Ti, SSC 2023-12-22
05060440333781Neoss Implant SystemIndividual Abutment, Ti, ASC 2023-12-22
05060440335860Neoss Implant SystemBridge Ti 2023-12-22
05060440335877Neoss Implant SystemBar Ti 2023-12-22
05060440336669Neoss Implant SystemDolder Bar Ti 2023-12-22
05060440335181Neoss Implant System41177411772020-02-24
05060440334924Neoss Implant System64015640152020-02-17
05060440334931Neoss Implant System64019640192020-02-17
05060440330926Neoss Implant System64010640102015-05-29
05060440330933Neoss Implant System64011640112015-05-29
05060440330940Neoss Implant System64012640122015-05-29
05060440330957Neoss Implant System64013640132015-05-29
05060440330964Neoss Implant System64014640142015-05-29
05060440331619Neoss Implant System64020640202015-08-26
05060440331626Neoss Implant System64021640212015-08-26
05060440334986Neoss Implant System51185511852020-01-27
05060440332661Neoss Implant System51150511502015-10-05
05060440332555Neoss Implant System51125511252015-10-05
05060440332081Neoss Implant System41178411782015-10-01
05060440332098Neoss Implant System41179411792015-10-01

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Primary DIBrandCompanyProduct codePublished
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08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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