RC Healing Abutment, conical shape

GUDID 06947600305545

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600305545
NIH Device Record Key6a429ce7-65a5-43be-9ae7-63b9d83f3484
Commercial Distribution StatusIn Commercial Distribution
Brand NameRC Healing Abutment, conical shape
Version Model Number122060
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
GS106947600305545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

Moist Heat or Steam Sterilization


[06947600305545]

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 [RC Healing Abutment, conical shape]

06947600305569122080
06947600305552122070
06947600305545122060
06947600305538122050
06947600305521122040
06947600305514122030
06947600303664122260
06947600303657122250
06947600303640122240
06947600303633122230
06947600303626122220
06947600303619122210

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