Magic Primilled Titanium Block

GUDID 08800039372091

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system
Primary Device ID08800039372091
NIH Device Record Key50371cc8-2701-4f6a-9782-a40328c111a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagic Primilled Titanium Block
Version Model NumberMC45H0520AB
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant 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 Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039372091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


[08800039372091]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-27
Device Publish Date2021-10-19

Devices Manufactured by InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

08800177337532 - Magicore S2024-12-25
08800177337617 - Magicore S2024-12-25
08800177337624 - Magicore S2024-12-25
08800177337631 - Magicore S2024-12-25
08800177337648 - Magicore S2024-12-25
08800177337723 - Magicore S2024-12-25
08800177337730 - Magicore S2024-12-25
08800177337747 - Magicore S2024-12-25

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