i-Clean SAVE Fixture

GUDID 08806169100177

Dental Implant System / i-Clean SAVE Fixture D5.5mm X L7.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169100177
NIH Device Record Key7055dda5-8216-4bc9-9c46-9988818de5f2
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean SAVE Fixture
Version Model NumberDIFS5507
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169100177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-30
Device Publish Date2015-07-31

On-Brand Devices [i-Clean SAVE Fixture]

08806169100245Dental Implant System / i-Clean SAVE Fixture D6.0mm X L12.0mm
08806169100238Dental Implant System / i-Clean SAVE Fixture D6.0mm X L10.0mm
08806169100221Dental Implant System / i-Clean SAVE Fixture D6.0mm X L8.0mm
08806169100214Dental Implant System / i-Clean SAVE Fixture D6.0mm X L7.0mm
08806169100207Dental Implant System / i-Clean SAVE Fixture D5.5mm X L12.0mm
08806169100191Dental Implant System / i-Clean SAVE Fixture D5.5mm X L10.0mm
08806169100184Dental Implant System / i-Clean SAVE Fixture D5.5mm X L8.0mm
08806169100177Dental Implant System / i-Clean SAVE Fixture D5.5mm X L7.0mm
08806169104991Dental Implant System / i-Clean SAVE Fixture D7.0mm X L12.0mm
08806169104984Dental Implant System / i-Clean SAVE Fixture D7.0mm X L10.0mm
08806169104977Dental Implant System / i-Clean SAVE Fixture D7.0mm X L8.0mm
08806169104960Dental Implant System / i-Clean SAVE Fixture D7.0mm X L7.0mm
08806169104953Dental Implant System / i-Clean SAVE Fixture D6.5mm X L12.0mm
08806169104946Dental Implant System / i-Clean SAVE Fixture D6.5mm X L10.0mm
08806169104939Dental Implant System / i-Clean SAVE Fixture D6.5mm X L8.0mm
08806169104922Dental Implant System / i-Clean SAVE Fixture D6.5mm X L7.0mm
08806169147714Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169147080Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169147073Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169147066Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169147059Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169147042Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169146939Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169146922Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169123374Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Closing Screw)
08806169123367Dental Implant System / i-Clean SAVE Fixture Set (Fixture + Closing Screw)
08806169144638Dental Implant System / i-Clean SAVE Fixture D6.0mm X L9.0mm
08806169144621Dental Implant System / i-Clean SAVE Fixture D5.5mm X L9.0mm
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