i-Clean Gold Cylinder

GUDID 08806169166098

Dental Implant System / i-Clean Gold Cylinder D6.8mm / Octa

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169166098
NIH Device Record Key3fae1174-1546-4c75-9725-15e9958ed289
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Gold Cylinder
Version Model NumberDIOGCWO
Company DUNS688204158
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
GS108806169166098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


[08806169166098]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-05-22

On-Brand Devices [i-Clean Gold Cylinder]

08806169100627Dental Implant System / i-Clean Gold Cylinder D5.0mm / Non-Octa
08806169100610Dental Implant System / i-Clean Gold Cylinder D5.0mm / Octa
08806169166104Dental Implant System / i-Clean Gold Cylinder D6.8mm / Non-Octa
08806169166098Dental Implant System / i-Clean Gold Cylinder D6.8mm / Octa
08806169109040Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)
08806169109033Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)
08806169166647Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)
08806169166630Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)

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