Twist drill, short, Φ 4.2mm

GUDID 06947600301523

BIO CONCEPT CO.,LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID06947600301523
NIH Device Record Key7dc54755-96de-4ec9-9779-225103bb22c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwist drill, short, Φ 4.2mm
Version Model Number051100
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
GS106947600301523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

Moist Heat or Steam Sterilization


[06947600301523]

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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06947600303756 - Impression post for closed tray,for screw-retained abutment,abutment level2022-09-13
06947600303763 - Impression Post for closed tray,for screw-retained abutment,abutment level2022-09-13
06947600303770 - Impression post for open tray,for screw-retained abutment,abutment level2022-09-13
06947600303787 - Impression Post for open tray,for screw-retained abutment,abutment level2022-09-13

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