i-Clean SAVE II Fixture

GUDID 08806169123411

Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169123411
NIH Device Record Keyfa22fda5-373a-46c7-b2da-6938ebd27bb7
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean SAVE II Fixture
Version Model NumberDI2FS55081S
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
GS108806169123411 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-20
Device Publish Date2019-06-12

On-Brand Devices [i-Clean SAVE II Fixture]

08806169123633Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123626Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123619Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123602Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123596Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123589Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123572Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123565Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123473Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123466Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123459Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123442Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123435Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123428Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123411Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169123404Dental Implant System / i-Clean SAVE II Fixture Set (Fixture + Closing Screw)
08806169144904Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L12.0mm
08806169144898Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L10.0mm
08806169144881Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L8.0mm
08806169144874Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L7.0mm
08806169144867Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L12.0mm
08806169144850Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L10.0mm
08806169144843Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L8.0mm
08806169144744Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L12.0mm
08806169144737Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L10.0mm
08806169144720Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L8.0mm
08806169144713Dental Implant System / i-Clean SAVE II Fixture D6.0mm X L7.0mm
08806169144706Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L12.0mm
08806169144690Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L10.0mm
08806169144683Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L8.0mm
08806169144676Dental Implant System / i-Clean SAVE II Fixture D5.5mm X L7.0mm
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