FDA.reportPublic FDA data

Neobiotech Implant System

Primary DI
08800329747899
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
BTSB4013
Device description
BT, Ø4.0, Hex
Published
2026-06-02
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
false

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
08800329747899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800329747899088003297478998800329747899

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08800263109357Neobiotech Implant SystemALXBTLA450P2026-04-24
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
00815967026143RodinPac-Dent, Inc.NDP2026-07-13
00815967029403RodinPac-Dent, Inc.NDP2026-07-13
06942799000004SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000035SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000042SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000073SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNDP2026-07-13
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660899Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660981Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09