OneQ-SL Implant

GUDID 08806169126528

Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L7.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169126528
NIH Device Record Keye500a393-15c1-4f2d-abc7-1bbe875e4b77
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneQ-SL Implant
Version Model NumberDISOF6552072
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
GS108806169126528 [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 Date2016-02-11

On-Brand Devices [OneQ-SL Implant]

08806169126528Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L7.0mm
08806169126337Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L8.0mm

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