Equator Abutment

GUDID 06947600313533

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600313533
NIH Device Record Key54f3c9db-ba0f-4244-adac-996d1f218f58
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquator Abutment
Version Model Number338060-1
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 Batchtrue
Serial Numberfalse
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
GS106947600313533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


[06947600313533]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-24
Device Publish Date2020-07-16

On-Brand Devices [Equator Abutment]

06947600313595338260-1
06947600313588338250-1
06947600313571338240-1
06947600313564338230-1
06947600313557338220-1
06947600313540338210-1
06947600313533338060-1
06947600313526338050-1
06947600313519338040-1
06947600313502338030-1
06947600313496338020-1
06947600313489338010-1
06947600313472338260
06947600313434338250
06947600313427338240
06947600313410338230
06947600313403338220
06947600313397338210
06947600313380338060
06947600313373338050
06947600313366338040
06947600313359338030
06947600313342338020
06947600313335338010
06947600306931134260-1
06947600306924134250-1
06947600306917134240-1
06947600306900134230-1
06947600306894134220-1
06947600306887134210-1
06947600306870134060-1
06947600306863134050-1
06947600306856134040-1
06947600306849134030-1
06947600306832134020-1
06947600306306134260
06947600306290134250
06947600306283134240
06947600306276134230
06947600306269134220
06947600306252134210
06947600305958134060
06947600305941134050
06947600305934134040
06947600305927134030
06947600305910134020

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