i-Clean Cylinder Screw

GUDID 08806169108791

Dental Implant System / i-Clean Cylinder Screw D2.5mm X L4.5mm

DENTIS CO., LTD.

Dental prosthesis/implant abutment screw
Primary Device ID08806169108791
NIH Device Record Key33c8c54c-0432-4ccb-9b22-88d2413dfc5d
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Cylinder Screw
Version Model NumberDIOACS
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
GS108806169105127 [Previous]
GS108806169108791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

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[08806169108791]

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[08806169108791]

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[08806169108791]

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[08806169108791]

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[08806169108791]

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[08806169108791]

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[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

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[08806169108791]

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[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

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[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


[08806169108791]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-08
Device Publish Date2015-08-26

Devices Manufactured by DENTIS CO., LTD.

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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
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08806169156006 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
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08806169156020 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm

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