i-Clean tapered II Fixture

GUDID 08806169124289

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

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169124289
NIH Device Record Key4331155d-7c1d-4d97-919f-589b675bef0c
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean tapered II Fixture
Version Model NumberDI2FR41101S
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
GS108806169124289 [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 Date2019-06-21
Device Publish Date2019-06-13

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

08806169174949Dental Implant System / i-Clelan tapered II Fixture D4.7mm X L14.0mm
08806169174932Dental Implant System / i-Clelan tapered II Fixture D4.7mm X L12.0mm
08806169174925Dental Implant System / i-Clelan tapered II Fixture D4.7mm X L10.0mm
08806169174918Dental Implant System / i-Clelan tapered II Fixture D4.7mm X L8.0mm
08806169124449Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124432Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124425Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124401Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124395Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124388Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124357Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124340Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124333Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124326Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124302Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124296Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124289Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124258Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124241Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169124234Dental Implant System / i-Clean tapered II Fixture Set (Fixture + Closing Screw)
08806169144614Dental Implant System / i-Clean tapered II Fixture D4.7mm X L14.0mm
08806169144607Dental Implant System / i-Clean tapered II Fixture D4.7mm X L12.0mm
08806169144591Dental Implant System / i-Clean tapered II Fixture D4.7mm X L10.0mm
08806169144584Dental Implant System / i-Clean tapered II Fixture D4.7mm X L8.0mm
08806169144560Dental Implant System / i-Clean tapered II Fixture D4.3mm X L14.0mm
08806169144553Dental Implant System / i-Clean tapered II Fixture D4.3mm X L12.0mm
08806169144546Dental Implant System / i-Clean tapered II Fixture D4.3mm X L10.0mm
08806169144539Dental Implant System / i-Clean tapered II Fixture D4.3mm X L8.0mm
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