Burn out core cap

GUDID 08800039303187

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

Dental implant system
Primary Device ID08800039303187
NIH Device Record Key6861193d-2506-4ac9-886a-c31ad222bb6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurn out core cap
Version Model NumberMPLP55B
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039303187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


[08800039303187]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

On-Brand Devices [Burn out core cap]

08800039303187MPLP55B
08800039303170MPLP45B

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