e-Clean tapered II Fixture

GUDID 08806169141699

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

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169141699
NIH Device Record Keyd1c7b9d4-af5a-4d29-89c9-8f8ebf7381aa
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-Clean tapered II Fixture
Version Model NumberDE2FR4108M
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
GS108806169141699 [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 II Fixture]

08806169123275Dental Implant System / e-Clean tapered II Fixture D3.5mm X L14.0mm
08806169123268Dental Implant System / e-Clean tapered II Fixture D3.5mm X L12.0mm
08806169123251Dental Implant System / e-Clean tapered II Fixture D3.5mm X L10.0mm
08806169123244Dental Implant System / e-Clean tapered II Fixture D3.5mm X L8.0mm
08806169142610Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141743Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141736Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141729Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141712Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141705Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141699Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141682Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141675Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141668Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169141651Dental Implant System / e-Clean tapered II Fixture Set (Fixture + Mount + Cover Screw + Mount Sc
08806169123343Dental Implant System / e-Clean tapered II Fixture D5.1mm X L12.0mm
08806169123336Dental Implant System / e-Clean tapered II Fixture D5.1mm X L10.0mm
08806169123329Dental Implant System / e-Clean tapered II Fixture D5.1mm X L8.0mm
08806169123312Dental Implant System / e-Clean tapered II Fixture D4.1mm X L14.0mm
08806169123305Dental Implant System / e-Clean tapered II Fixture D4.1mm X L12.0mm
08806169123299Dental Implant System / e-Clean tapered II Fixture D4.1mm X L10.0mm
08806169123282Dental Implant System / e-Clean tapered II Fixture D4.1mm X L8.0mm
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