FDA.report

Neobiotech Implant System

Primary DI
08809407158299
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
SABC01
Device description
Ø1.0/2.2
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
08809407158299PrimaryGS10

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

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08809737570198Neobiotech Implant SystemIS36006A2026-02-25
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08809737575407Neobiotech Implant SystemISANMUA3440S2026-02-25
08809737575414Neobiotech Implant SystemISANMUA3430S2026-02-25
08809737575421Neobiotech Implant SystemISANMUA3420S2026-02-25
08809737575438Neobiotech Implant SystemISANMUA3410S2026-02-25
08809737575445Neobiotech Implant SystemISANMUA1440S2026-02-25
08809737575452Neobiotech Implant SystemISANMUA1430S2026-02-25
08809737575469Neobiotech Implant SystemISANMUA1420S2026-02-25
08809737575476Neobiotech Implant SystemISANMUA1410S2026-02-25

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