i-Clean Abutment Screw

GUDID 08806169104588

Dental Implant System / i-Clean Abutment Screw D2.5mm X L7.1mm

DENTIS CO., LTD.

Dental prosthesis/implant abutment screw
Primary Device ID08806169104588
NIH Device Record Key0964f958-55af-4352-8d8b-00a05381958d
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Abutment Screw
Version Model NumberDIAAS
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
GS108806169104588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


[08806169104588]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-08
Device Publish Date2015-07-30

Devices Manufactured by DENTIS CO., LTD.

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08800053022385 - s-Clean SQ-SL Fixture2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
08806169155979 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
08806169155986 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
08806169155993 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
08806169156006 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
08806169156013 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
08806169156020 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm

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