Endo Rotary file

GUDID 06970873260112

K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill.

DENJOY DENTAL CO.,LTD

Margin finishing dental file/rasp, reusable
Primary Device ID06970873260112
NIH Device Record Keyeedba507-5864-4fab-b8fa-00130741ebe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo Rotary file
Version Model NumberK file, Machine super file, Machine H file, G file
Company DUNS529329650
Company NameDENJOY DENTAL CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970873260112 [Primary]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


[06970873260112]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-28
Device Publish Date2022-02-19

Devices Manufactured by DENJOY DENTAL CO.,LTD

06970873260013 - PULP TESTER2022-02-28
06970873260051 - Endo Motor 2022-02-28
06970873260068 - Endo Motor 2022-02-28
06970873260075 - Endo Motor 2022-02-28
06970873260082 - Cordless Gutta percha obturation system 2022-02-28
06970873260112 - Endo Rotary file 2022-02-28K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill.
06970873260112 - Endo Rotary file 2022-02-28 K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH
06970873260143 - Gutta percha obturation system 2022-02-28
06970873260167 - Medical Microscope2022-02-28

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