e-Clean tapered Fixture

GUDID 08806169141064

Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169141064
NIH Device Record Key2cd91389-e537-4f69-b040-485f7d9d27b7
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-Clean tapered Fixture
Version Model NumberDEFM3514S
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
GS108806169141064 [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 Date2019-06-20
Device Publish Date2019-06-12

On-Brand Devices [e-Clean tapered Fixture]

08806169102829Dental Implant System / e-Clean tapered Fixture D5.1mm X L14.0mm
08806169102812Dental Implant System / e-Clean tapered Fixture D5.1mm X L12.0mm
08806169102805Dental Implant System / e-Clean tapered Fixture D5.1mm X L10.0mm
08806169102799Dental Implant System / e-Clean tapered Fixture D5.1mm X L8.0mm
08806169102782Dental Implant System / e-Clean tapered Fixture D4.1mm X L14.0mm
08806169102775Dental Implant System / e-Clean tapered Fixture D4.1mm X L12.0mm
08806169102768Dental Implant System / e-Clean tapered Fixture D4.1mm X L10.0mm
08806169102751Dental Implant System / e-Clean tapered Fixture D4.1mm X L8.0mm
08806169102744Dental Implant System / e-Clean tapered Fixture D3.5mm X L14.0mm
08806169102737Dental Implant System / e-Clean tapered Fixture D3.5mm X L12.0mm
08806169102720Dental Implant System / e-Clean tapered Fixture D3.5mm X L10.0mm
08806169102713Dental Implant System / e-Clean tapered Fixture D3.5mm X L8.0mm
08806169141477Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141460Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141453Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141446Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141439Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141422Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141415Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141408Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141392Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141385Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141378Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
08806169141231Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141224Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141132Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141101Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141095Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141088Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141071Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141064Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141057Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141040Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169141033Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)

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