s-Clean SAVE II Fixture

GUDID 08806169150134

Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L10.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169150134
NIH Device Record Key5827aafa-4f54-4628-b926-eed3e6bf047e
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean SAVE II Fixture
Version Model NumberDS2FS5510
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
GS108806169150134 [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 Date2019-06-12
Device Publish Date2019-06-04

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

08806169125408Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125392Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125385Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125378Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125361Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125354Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125347Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125330Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125323Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169125316Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
08806169150196Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L12.0mm
08806169150189Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L10.0mm
08806169150172Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L9.0mm
08806169150165Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L8.0mm
08806169150158Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L7.0mm
08806169150141Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L12.0mm
08806169150134Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L10.0mm
08806169150127Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L9.0mm
08806169150110Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L8.0mm
08806169150103Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L7.0mm

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