Neobiotech Implant System

GUDID 08809486295625

Ø7.0*7.0mm

Neobiotech. co., ltd

Dental implant system
Primary Device ID08809486295625
NIH Device Record Key602aa893-54cc-4faa-a8df-c47582035708
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeobiotech Implant System
Version Model NumberITW327007AP
Company DUNS688371566
Company NameNeobiotech. co., ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809486295625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-26
Device Publish Date2019-09-18

On-Brand Devices [Neobiotech Implant System]

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08809407155281Ø4.5*3mm
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08809407155229Ø4.0*2mm
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08809486290347Ø4.8*5.8mm
08809486293782Ø3.6*6.4mm
08809486293775Ø3.45*5.85mm
08809486292723Ø5.5*2.8mm
08809486290460Ø5.5*3.8mm
08809486290361Ø5.5*5.8mm
08809486290354Ø5.5*4.8mm
08809486290330Ø4.8*4.8mm
08809486290255Ø5.5*7.8mm
08809486290248Ø5.5*6.8mm
08809486290217Ø4.8*7mm
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08809407154468Ø9.0*3.8mm
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08809407154413Ø8.0*4.8mm
08809407154406Ø8.0*3.8mm
08809407154390Ø8.0*2.8mm
08809407154383Ø6.8*7.8mm
08809407154376Ø6.8*6.8mm
08809407154369Ø6.8*5.8mm
08809407154352Ø6.8*4.8mm
08809407154345Ø6.8*3.8mm
08809407154338Ø6.8*2.8mm
08809407154321Ø6.0*7.8mm
08809407154314Ø6.0*6.8mm
08809407154307Ø6.0*5.8mm
08809407154291Ø6.0*4.8mm
08809407154284Ø6.0*3.8mm
08809407154277Ø6.0*2.8mm
08809407151351Ø6.5*5mm, L:6.5mm
08809407151245Ø6.5*2mm, L:4.0mm
08809407150491Ø4.5*4mm, L:7.0mm
08809276764294Ø7.0*13.0mm
08809276764270Ø7.0*11.5mm
08809276764256Ø7.0*10.0mm
08809276764232Ø7.0*8.5mm
08809276764218Ø7.0*7.3mm
08809276764195Ø6.0*13.0mm
08809276764171Ø6.0*11.5mm

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