RN Positioning Cylinder for Solid Abutment 032010

GUDID 06947600302667

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600302667
NIH Device Record Key5d9851af-1029-418e-b09d-ae4fd3f685bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameRN Positioning Cylinder for Solid Abutment 032010
Version Model Number062060
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
GS106947600302186 [Primary]
GS106947600302667 [Package]
Contains: 06947600302186
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

Moist Heat or Steam Sterilization


[06947600302667]

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

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06947600319030 - Initial Drill,Φ3.5mm/Φ5.7mm,L5mm2024-09-26
06947600319047 - Initial Drill,Φ2.7mm/Φ5mm,L5mm2024-09-26
06947600319054 - Initial Drill,Φ3.5mm/Φ5mm,L5mm2024-09-26
06947600319061 - Initial Drill,Φ2.7mm/Φ5mm,L7mm2024-09-26
06947600319078 - Initial Drill,Φ2.7mm/Φ5mm,L8.5mm2024-09-26
06947600319085 - Initial Drill,Φ2.7mm/Φ5mm,L10mm2024-09-26

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