i-Clean tapered Fixture

GUDID 08806169100047

Dental Implant System / i-Clean tapered Fixture D4.3mm X L8.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169100047
NIH Device Record Keybd802295-c050-4bd9-add3-6f496ad7c5cf
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean tapered Fixture
Version Model NumberDIFR4308
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
GS108806169100047 [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 Date2019-05-07
Device Publish Date2015-07-27

On-Brand Devices [i-Clean tapered Fixture]

08806169100009Dental Implant System / i-Clean tapered Fixture D3.7mm X L8.0mm
08806169100115Dental Implant System / i-Clean tapered Fixture D4.7mm X L14.0mm
08806169100108Dental Implant System / i-Clean tapered Fixture D4.7mm X L12.0mm
08806169100092Dental Implant System / i-Clean tapered Fixture D4.7mm X L10.0mm
08806169100085Dental Implant System / i-Clean tapered Fixture D4.7mm X L8.0mm
08806169100078Dental Implant System / i-Clean tapered Fixture D4.3mm X L14.0mm
08806169100061Dental Implant System / i-Clean tapered Fixture D4.3mm X L12.0mm
08806169100054Dental Implant System / i-Clean tapered Fixture D4.3mm X L10.0mm
08806169100047Dental Implant System / i-Clean tapered Fixture D4.3mm X L8.0mm
08806169100030Dental Implant System / i-Clean tapered Fixture D3.7mm X L14.0mm
08806169100023Dental Implant System / i-Clean tapered Fixture D3.7mm X L12.0mm
08806169100016Dental Implant System / i-Clean tapered Fixture D3.7mm X L10.0mm
08806169124203Dental Implant System / i-Clean tapered Fixture D4.7mm X L14.0mm
08806169124197Dental Implant System / i-Clean tapered Fixture D4.7mm X L12.0mm
08806169124180Dental Implant System / i-Clean tapered Fixture D4.7mm X L10.0mm
08806169124173Dental Implant System / i-Clean tapered Fixture D4.7mm X L8.0mm
08806169124135Dental Implant System / i-Clean tapered Fixture D4.1mm X L14.0mm
08806169124128Dental Implant System / i-Clean tapered Fixture D4.1mm X L12.0mm
08806169124111Dental Implant System / i-Clean tapered Fixture D4.1mm X L10.0mm
08806169124104Dental Implant System / i-Clean tapered Fixture D4.1mm X L8.0mm
08806169146748Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146632Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146625Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146618Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146601Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146595Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146496Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146489Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146472Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169146465Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145819Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145802Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145796Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145772Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145765Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145758Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145741Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145734Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145659Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169145642Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)

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