FDA.reportPublic FDA data

Neobiotech Implant System

Primary DI
08800263109388
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
ALXBTLA450
Device description
2.5 Hex, Bone Level Ø4.5 Only
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
08800263109388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800263109388088002631093888800263109388

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688371566
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800394921170Neobiotech Implant SystemBTPCIB35022026-09-22
08800394921187Neobiotech Implant SystemBTPCIB35032026-09-22
08800394921194Neobiotech Implant SystemBTPCIB35042026-09-22
08800394921200Neobiotech Implant SystemBTPCIB48022026-09-22
08800394921217Neobiotech Implant SystemBTPCIB48032026-09-22
08800394921224Neobiotech Implant SystemBTPCIB48042026-09-22
08800394921231Neobiotech Implant SystemBTPCI3502C2026-09-22
08800394921248Neobiotech Implant SystemBTPCI3503C2026-09-22
08800394921255Neobiotech Implant SystemBTPCI3504C2026-09-22
08800394921262Neobiotech Implant SystemBTPCI4802C2026-09-22
08800394921279Neobiotech Implant SystemBTPCI4803C2026-09-22
08800394921286Neobiotech Implant SystemBTPCI4804C2026-09-22
08800394921293Neobiotech Implant SystemALXMAXY322026-09-22
08800394921309Neobiotech Implant SystemATD2528142026-09-22
08800394921316Neobiotech Implant SystemATSD2532082026-09-22
08800394921323Neobiotech Implant SystemATSD2532102026-09-22
08800394921330Neobiotech Implant SystemATSD2532122026-09-22
08800394921347Neobiotech Implant SystemATSD3235082026-09-22
08800394921354Neobiotech Implant SystemATSD3235102026-09-22
08800394921361Neobiotech Implant SystemATSD3542082026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002021Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002038Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002045Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002052Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002069Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002076Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002397Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14