i-Clean Plastic Cylinder

GUDID 08800053040006

i-Clean Plastic Cylinder (DIOPWOS)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08800053040006
NIH Device Record Keyf37b615c-fd42-45eb-9adf-f41138b6e137
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Plastic Cylinder
Version Model NumberDIOPWOS
Company DUNS694721181
Company NameDENTIS 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 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
GS108800053040006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


[08800053040006]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

On-Brand Devices [i-Clean Plastic Cylinder]

08800053023047Dental Implant Instrument / i-Clean Plastic Cylinder
08800053023030Dental Implant Instrument / i-Clean Plastic Cylinder
08800053040006i-Clean Plastic Cylinder (DIOPWOS)
08800053039994i-Clean Plastic Cylinder (DIOPWNS)
08800053037907i-Clean Plastic Cylinder (DIOPNS)
08800053037891i-Clean Plastic Cylinder (DIOPOS)

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