Root Canal Instruments Kit

GUDID 06970873260297

DENJOY DENTAL CO.,LTD

Dental examination kit
Primary Device ID06970873260297
NIH Device Record Key89a46a59-6224-4156-b44d-870ae53a0cca
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoot Canal Instruments Kit
Version Model NumberDY21-1
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 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
GS106970873260297 [Primary]

FDA Product Code

NYCDental Prophylaxis Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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 2022-02-28 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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