OneQ-SL s-Clean Fixture DSSOFW8010s

GUDID 08806169127778

Ø8.0x10mm

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece
Primary Device ID08806169127778
NIH Device Record Keyd8537e28-2ea9-43b0-a85a-f51e0a930398
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneQ-SL s-Clean Fixture
Version Model NumberDSSOFW8010
Catalog NumberDSSOFW8010s
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
GS108806169127778 [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 Date2020-07-27
Device Publish Date2016-05-18

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