NEXPLANT SMUA-3517

GUDID 08800024918921

Multi Angled Abutment / 17 degree / Diameter: 4.8mm / Length: 7.45mm

Achimhai Medical Corporation

Dental implant suprastructure, permanent, preformed
Primary Device ID08800024918921
NIH Device Record Key4fe9f775-92a6-445d-b450-3cd0e874f776
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEXPLANT
Version Model NumberSMUA-3517
Catalog NumberSMUA-3517
Company DUNS694197900
Company NameAchimhai Medical Corporation
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800024918921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

[08800024918921]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-12
Device Publish Date2021-11-04

On-Brand Devices [NEXPLANT]

08800024935324Abutment Screw M1.4
08800024935119Duplex Abutment Φ3.5/GH4.0/ANGLE25 Hex
08800024935102Duplex Abutment Φ3.5/GH3.0/ANGLE25 Hex
08800024935096Duplex Abutment Φ3.5/GH2.0/ANGLE25 Hex
08800024935089Duplex Abutment Φ3.5/GH4.0/ANGLE15 Hex
08800024935072Duplex Abutment Φ3.5/GH3.0/ANGLE15 Hex
08800024935065Duplex Abutment Φ3.5/GH2.0/ANGLE15 Hex
08800024918808Hex 1.2 / Short
08800024917771Ø4.5 / Non-Hex
08800024917764Ø4.5 / Hex
08800024917757Ø4.0 / Non-Hex
08800024917740Ø4.0 / Hex
08800024917467Ø5.5 / H=7.0mm
08800024917450Ø5.5 / H=5.0mm
08800024917443Ø5.5 / H=3.5mm
08800024917436Ø4.5 / H=7.0mm
08800024917429Ø4.5 / H=5.0mm
08800024917412Ø4.5 / H=3.5mm
08800024917405Ø4.0 / H=7.0mm
08800024917399Ø4.0 / H=5.0mm
08800024917382Ø4.0 / H=3.5mm
08800024917375Duplex Abutment Φ3.5/GH4.5/PH7.0 Hex
08800024917368Duplex Abutment Φ3.5/GH3.5/PH7.0 Hex
08800024917351Duplex Abutment Φ3.5/GH2.5/PH7.0 Hex
08800024917344Duplex Abutment Φ3.5/GH1.5/PH7.0 Hex
08800024917337Duplex Abutment Φ3.5/GH1.0/PH7.0 Hex
08800024917320Duplex Abutment Φ3.5/GH4.5/PH5.5 Hex
08800024917313Duplex Abutment Φ3.5/GH3.5/PH5.5 Hex
08800024917306Duplex Abutment Φ3.5/GH2.5/PH5.5 Hex
08800024917290Duplex Abutment Φ3.5/GH1.5/PH5.5 Hex
08800024917283Duplex Abutment Φ3.5/GH1.0/PH5.5 Hex
08800024918839Hex 3.5mm
08800024918822Hex 1.25 / Short
08800024918815Hex 1.25 / Long
08800024918792Hex 1.2 / Long
08800024918785Drill extension
08800024918228Ø5.5 / Non-Hex / Long
08800024918211Ø4.5 / Non-Hex / Long
08800024918204Ø4.0 / Non-Hex / Long
08800024918198Ø5.5 / Non-Hex / Short
08800024918181Ø4.5 / Non-Hex / Short
08800024918174Ø4.0 / Non-Hex / Short
08800024918082Ø5.5 / Hex / Long
08800024918075Ø4.5 / Hex / Long
08800024918068Ø4.0 / Hex / Long
08800024918051Ø5.5 / Hex / Short
08800024918044Ø4.5 / Hex / Short
08800024918037Ø4.0 / Hex / Short
08800024954615Ø2.0 / Ø2.7
08800024954608Ø5.0 / L=11.0mm

Trademark Results [NEXPLANT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEXPLANT
NEXPLANT
87139945 5367457 Live/Registered
SAMSUNG SDS CO., LTD.
2016-08-16
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.