HAPTITE i-Clean straight Fixture

GUDID 08806169158789

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

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece
Primary Device ID08806169158789
NIH Device Record Key7eac4eae-c3c1-4f78-a3b0-472e99024b47
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPTITE i-Clean straight Fixture
Version Model NumberDISF4812LHS
Company DUNS694721181
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
GS108806169158789 [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 Number2
Public Version Date2020-07-27
Device Publish Date2019-05-14

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

08806169158840Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158796Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)
08806169158789Dental Implant System / HAPTITE i-Clean straight Fixture Set (Fixture + Cover Screw)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.