i-Clean Healing Abutment

GUDID 08806169132499

Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height3.0mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806169132499
NIH Device Record Key914f2da2-6992-488e-9de9-7daf54e06b36
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Healing Abutment
Version Model NumberDIWH30
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169132499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-31
Device Publish Date2019-05-23

On-Brand Devices [i-Clean Healing Abutment]

08806169100283Dental Implant System / i-Clean Healing Abutment D6.4mm, Post Height5.5mm
08806169100276Dental Implant System / i-Clean Healing Abutment D6.4mm, Post Height4.0mm
08806169100269Dental Implant System / i-Clean Healing Abutment D6.4mm, Post Height3.0mm
08806169100160Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height5.5mm
08806169100153Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height4.0mm
08806169100146Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height3.0mm
08806169105011Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height7.0mm
08806169105004Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height2.0mm
08806169132512Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height5.5mm
08806169132505Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height4.0mm
08806169132499Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height3.0mm
08806169132482Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height2.0mm
08806169132475Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height4.5mm

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