I-FIX Abutment Screw

GUDID 08806169104373

Dental Implant System / I-FIX Abutment Screw D2.2mm X L4.05mm

DENTIS CO., LTD.

Dental prosthesis/implant abutment screw

Primary Device ID	08806169104373
NIH Device Record Key	91bf6a3c-4c39-4b9f-bbc5-ab0075708809
Commercial Distribution Status	In Commercial Distribution
Brand Name	I-FIX Abutment Screw
Version Model Number	DMAS
Company DUNS	688204158
Company Name	DENTIS CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169104373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K083586

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

[08806169104373]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2019-05-08
Device Publish Date	2015-07-31

Devices Manufactured by DENTIS CO., LTD.

08800053035163 - s-Clean SQ-SL Fixture	2021-03-10 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
08800053022385 - s-Clean SQ-SL Fixture	2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
08806169155979 - s-Clean SQ-SL Fixture	2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
08806169155986 - s-Clean SQ-SL Fixture	2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
08806169155993 - s-Clean SQ-SL Fixture	2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
08806169156006 - s-Clean SQ-SL Fixture	2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
08806169156013 - s-Clean SQ-SL Fixture	2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
08806169156020 - s-Clean SQ-SL Fixture	2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm

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