i-Clean Octa Abutment Healing Cap

GUDID 08806169166067

Dental Implant System / i-Clean Octa Healing Cap D6.6mm X L4.3mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806169166067
NIH Device Record Key62c8355f-caec-4d29-beda-5e9b71ae86d0
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Octa Abutment Healing Cap
Version Model NumberDIOWHC
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
GS108806169166067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


[08806169166067]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-30
Device Publish Date2019-05-22

On-Brand Devices [i-Clean Octa Abutment Healing Cap]

08806169166067Dental Implant System / i-Clean Octa Healing Cap D6.6mm X L4.3mm
08806169131751Dental Implant System / i-Clean Octa Healing Cap D6.6mm X L4.0mm
08806169112071Dental Implant System / i-Clean Healing Cap Set (Healing Cap + Cylinder Screw)

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