i-Clean Solid Abutment

GUDID 08806169112873

Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169112873
NIH Device Record Key68c9b69c-8649-489a-93ff-999c59dc420a
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Solid Abutment
Version Model NumberDISAW40S
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
GS108806169112873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

Moist Heat or Steam Sterilization


[08806169112873]

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 Solid Abutment]

00880616910030Ø3.5, H:5.5mm
08806169100306Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height5.5mm
08806169100313Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height7.0mm
08806169100290Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height4.0mm
08806169105042Dental Implant System / i-Clean Solid Abutment D3.5mm X L8.0mm
08806169112897Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
08806169112880Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
08806169112873Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
08806169166159Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
08806169166142Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
08806169166135Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
08806169166128Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)

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