HAPTITE i-Clean tapered Fixture

GUDID 08806169156846

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

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169156846
NIH Device Record Key44ec93bc-a851-4dc3-a37a-771e82354a6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPTITE i-Clean tapered Fixture
Version Model NumberDIFM3714HS
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
GS108806169156846 [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 Date2019-06-05
Device Publish Date2019-05-28

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

08806169106100Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L10.0mm
08806169106094Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L8.0mm
08806169106070Dental Implant System / HAPTITE i-Clean tapered Fixture D4.3mm X L14.0mm
08806169106063Dental Implant System / HAPTITE i-Clean tapered Fixture D4.3mm X L12.0mm
08806169106056Dental Implant System / HAPTITE i-Clean tapered Fixture D4.3mm X L10.0mm
08806169106049Dental Implant System / HAPTITE i-Clean tapered Fixture D4.3mm X L8.0mm
08806169106032Dental Implant System / HAPTITE i-Clean tapered Fixture D4.3mm X L7.0mm
08806169106025Dental Implant System / HAPTITE i-Clean tapered Fixture D4.1mm X L14.0mm
08806169106018Dental Implant System / HAPTITE i-Clean tapered Fixture D4.1mm X L12.0mm
08806169106001Dental Implant System / HAPTITE i-Clean tapered Fixture D4.1mm X L10.0mm
08806169105998Dental Implant System / HAPTITE i-Clean tapered Fixture D4.1mm X L8.0mm
08806169105981Dental Implant System / HAPTITE i-Clean tapered Fixture D4.1mm X L7.0mm
08806169105974Dental Implant System / HAPTITE i-Clean tapered Fixture D3.7mm X L14.0mm
08806169105967Dental Implant System / HAPTITE i-Clean tapered Fixture D3.7mm X L11.0mm
08806169105950Dental Implant System / HAPTITE i-Clean tapered Fixture D3.7mm X L10.0mm
08806169105943Dental Implant System / HAPTITE i-Clean tapered Fixture D3.7mm X L8.0mm
08806169105936Dental Implant System / HAPTITE i-Clean tapered Fixture D3.7mm X L7.0mm
08806169106179Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L14.0mm
08806169106162Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L12.0mm
08806169106155Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L10.0mm
08806169106148Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L8.0mm
08806169106131Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L7.0mm
08806169106124Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L14.0mm
08806169106117Dental Implant System / HAPTITE i-Clean tapered Fixture D4.7mm X L12.0mm
08806169174499Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157768Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157713Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157706Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157164Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157157Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157140Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169157133Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156969Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156952Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156945Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156938Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156921Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156914Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156907Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156891Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156884Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156877Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156860Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156853Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156846Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156839Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156822Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156662Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
08806169156655Dental Implant System / HAPTITE i-Clean tapered Fixture Set (Fixture + Cover Screw)
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