HAPTITE i-Clean SAVE Fixture

GUDID 08806169159038

Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID08806169159038
NIH Device Record Key33c9ebd8-b131-4b67-880d-4009cc8f4237
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPTITE i-Clean SAVE Fixture
Version Model NumberDIFS6008HS
Company DUNS694721181
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
GS108806169159038 [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 Number2
Public Version Date2020-07-27
Device Publish Date2019-05-14

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

08806169159038Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169159021Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169158970Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169158963Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169158918Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169158901Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)
08806169158857Dental Implant System / HAPTITE i-Clean SAVE Fixture Set (Fixture + Cover Screw)

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