FDA.report

Neobiotech Implant System

Primary DI
08809815659937
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
NGSS08
Device description
8.0mm
Published
2022-11-28
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

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809815659937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809815659937088098156599378809815659937

GMDN Terms

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
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 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
08809876904793Neobiotech Implant SystemISPTC4402026-03-04
08809876904885Neobiotech Implant SystemISPTC5402026-03-04
08809876904892Neobiotech Implant SystemISPTC6402026-03-04
08809486290101Neobiotech Implant SystemMUAHC482026-02-25
08809486293515Neobiotech Implant SystemIS35006AP2026-02-25
08809486293522Neobiotech Implant SystemIS35506AP2026-02-25
08809737570167Neobiotech Implant SystemIS36006AP2026-02-25
08809737570174Neobiotech Implant SystemIS35006A2026-02-25
08809737570181Neobiotech Implant SystemIS35506A2026-02-25
08809737570198Neobiotech Implant SystemIS36006A2026-02-25

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