NC Healing Abutment, conical shape

GUDID 06947600305293

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600305293
NIH Device Record Key7c0b2baf-3687-4265-bb83-1e1b556a8a17
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Healing Abutment, conical shape
Version Model Number121050
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
GS106947600305293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

Moist Heat or Steam Sterilization


[06947600305293]

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 [NC Healing Abutment, conical shape]

06947600305347121100
06947600305330121090
06947600305323121080
06947600305293121050
06947600305286121040
06947600305279121030

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