FDA.reportPublic FDA data

Neobiotech Implant System

Primary DI
08809486292860
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
IS3H4510P
Device description
Ø4.5*10.0mm
Published
2018-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173938000IS-III HActive FixtureNeobiotech Co., Ltd.2018-05-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809486292860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809486292860088094862928608809486292860

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

Regulatory Flags#

DUNS number
688371566
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28