RN Healing cap, labial bevel

GUDID 06947600301042

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600301042
NIH Device Record Key4a4f833a-adb4-4c54-8900-dbfb262f992e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRN Healing cap, labial bevel
Version Model Number022060
Company DUNS527603266
Company NameBIO CONCEPT 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600301042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


[06947600301042]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-19
Device Publish Date2016-09-01

On-Brand Devices [RN Healing cap, labial bevel]

06947600301059022070
06947600301042022060

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