HAPTITE i-Clean straight Fixture

GUDID 08806169106520

Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L12.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169106520
NIH Device Record Keyd294fe82-b193-4709-b8b6-f15ef1d907e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPTITE i-Clean straight Fixture
Version Model NumberDISF4112LH
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
GS108806169106520 [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 Date2015-08-21

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

08806169106438Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L7.0mm
08806169106780Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L16.0mm
08806169106773Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L14.0mm
08806169106766Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L12.0mm
08806169106759Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L10.0mm
08806169106742Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L8.0mm
08806169106735Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L7.0mm
08806169106728Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L16.0mm
08806169106711Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L14.0mm
08806169106704Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L12.0mm
08806169106698Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L10.0mm
08806169106681Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L8.0mm
08806169106674Dental Implant System / HAPTITE i-Clean straight Fixture D4.8mm X L7.0mm
08806169106667Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L16.0mm
08806169106650Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L14.0mm
08806169106643Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L12.0mm
08806169106636Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L10.0mm
08806169106629Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L8.0mm
08806169106612Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L7.0mm
08806169106605Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L16.0mm
08806169106599Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L14.0mm
08806169106582Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L12.0mm
08806169106575Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L10.0mm
08806169106568Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L8.0mm
08806169106551Dental Implant System / HAPTITE i-Clean straight Fixture D4.3mm X L7.0mm
08806169106544Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L16.0mm
08806169106537Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L14.0mm
08806169106520Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L12.0mm
08806169106513Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L10.0mm
08806169106506Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L8.0mm
08806169106490Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L7.0mm
08806169106483Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L16.0mm
08806169106476Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L14.0mm
08806169106469Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L12.0mm
08806169106452Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L10.0mm
08806169106445Dental Implant System / HAPTITE i-Clean straight Fixture D4.1mm X L8.0mm
08806169158734Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158727Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158673Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158666Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158611Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158604Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158550Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158543Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158499Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158482Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158437Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158420Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158376Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158369Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
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