FDA.report

Neobiotech Implant System

Primary DI
08809407155342
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
ISUPH600
Device description
Ø5.7, L:10.0mm
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809407155342PrimaryGS10

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

Regulatory Flags

DUNS number
688371566
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

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08809486290101Neobiotech Implant SystemMUAHC482026-02-25
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08809737570181Neobiotech Implant SystemIS35506A2026-02-25
08809737570198Neobiotech Implant SystemIS36006A2026-02-25
08809737575360Neobiotech Implant SystemMUAS142026-02-25
08809737575391Neobiotech Implant SystemMUATPCN482026-02-25
08809737575407Neobiotech Implant SystemISANMUA3440S2026-02-25
08809737575414Neobiotech Implant SystemISANMUA3430S2026-02-25
08809737575421Neobiotech Implant SystemISANMUA3420S2026-02-25
08809737575438Neobiotech Implant SystemISANMUA3410S2026-02-25
08809737575445Neobiotech Implant SystemISANMUA1440S2026-02-25
08809737575452Neobiotech Implant SystemISANMUA1430S2026-02-25
08809737575469Neobiotech Implant SystemISANMUA1420S2026-02-25
08809737575476Neobiotech Implant SystemISANMUA1410S2026-02-25

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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
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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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