FDA.reportPublic FDA data

Neobiotech Implant System

Primary DI
08800263109357
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
ALXBTLA450P
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
08800263109357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800263109357088002631093578800263109357

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
08800329747899Neobiotech Implant SystemBTSB40132026-06-02
08800263109418Neobiotech Implant SystemDLACL37P2026-05-22
08800263109425Neobiotech Implant SystemDLACL48P2026-05-22
08800263109432Neobiotech Implant SystemDLACL52P2026-05-22
08800263109449Neobiotech Implant SystemDLACL55P2026-05-22
08800263109456Neobiotech Implant SystemDLACL65P2026-05-22
08800263109463Neobiotech Implant SystemDLACL372026-05-22
08800263109470Neobiotech Implant SystemDLACL482026-05-22
08800263109487Neobiotech Implant SystemDLACL522026-05-22
08800263109494Neobiotech Implant SystemDLACL552026-05-22
08800263109500Neobiotech Implant SystemDLACL652026-05-22
08800329744157Neobiotech Implant SystemALXBTFDNC2026-04-30
08800329744164Neobiotech Implant SystemALXBTFDNCL2026-04-30
08800329744171Neobiotech Implant SystemALXBTFDNR2026-04-30
08800329744188Neobiotech Implant SystemALXBTFDNRL2026-04-30
08800263109340Neobiotech Implant SystemALXBTLA350P2026-04-24
08800263109364Neobiotech Implant SystemALXBTLA500P2026-04-24
08800263109371Neobiotech Implant SystemALXBTLA3502026-04-24
08800263109388Neobiotech Implant SystemALXBTLA4502026-04-24
08800263109395Neobiotech Implant SystemALXBTLA5002026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810646Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810653Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810684Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810691Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810707Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810714Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810721Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810738Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810745Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810752Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810769Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18