HAPTITE i-Clean tapered Fixture DIFWR4807HS

GUDID 08806169106087

Ø4.8x7mm

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece
Primary Device ID08806169106087
NIH Device Record Key8c6c1aa0-f50d-484a-9cee-05b68d428af7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAPTITE i-Clean tapered Fixture
Version Model NumberDIFWR4807H
Catalog NumberDIFWR4807HS
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
GS108806169106087 [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 Date2020-07-27
Device Publish Date2015-08-21

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