i-Clean O-Ring Abutment

GUDID 08806169100771

Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L9.1mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169100771
NIH Device Record Key2b2e9a0d-0b87-4446-b7bd-4012f4b63200
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean O-Ring Abutment
Version Model NumberDIORA00
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
GS108806169100771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


[08806169100771]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-08-21

On-Brand Devices [i-Clean O-Ring Abutment]

08806169100795Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L13.1mm
08806169100788Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L11.1mm
08806169100771Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L9.1mm
08806169131782Dental Implant System / i-Clean O-Ring Abutmnent D4.3mm X L13.4mm
08806169131775Dental Implant System / i-Clean O-Ring Abutmnent D4.3mm X L11.4mm
08806169131768Dental Implant System / i-Clean O-Ring Abutmnent D4.3mm X L9.4mm

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