OneQ Smart KIT

GUDID 08806169145499

Dental Implant Instrument KIT/ OneQ Smart KIT

DENTIS CO. ,LTD

Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit
Primary Device ID08806169145499
NIH Device Record Key445a75c7-ee76-489e-8f1c-db989711cb32
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneQ Smart KIT
Version Model NumberDIOSK
Company DUNS694721181
Company NameDENTIS CO. ,LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169145499 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


[08806169145499]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by DENTIS CO. ,LTD

08800053005173 - Marking drill2021-06-11 Dental Implant Instrument / Marking drill
08800053005487 - s-Clean HI Bite Coping2021-06-11 Dental Implant Instrument / s-Clean HI Bite Coping
08800053005494 - s-Clean HI Bite Coping2021-06-11 Dental Implant Instrument / s-Clean HI Bite Coping
08800053005500 - s-Clean HI Bite Coping2021-06-11 Dental Implant Instrument / s-Clean HI Bite Coping
08800053006439 - Carbide Bur2021-06-11 Dental Implant Instrument / Carbide Bur
08800053006446 - Carbide Bur2021-06-11 Dental Implant Instrument / Carbide Bur
08800053006989 - SQ Step Drill2021-06-11 Dental Implant Instrument / SQ Step Drill
08800053006996 - SQ Step Drill2021-06-11 Dental Implant Instrument / SQ Step Drill

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.