ET IV Fixture SA Ultra-Wide No Mount

GUDID 00814913029061

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913029061
NIH Device Record Keya24a125e-533d-471b-bc87-ae8220bca7ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameET IV Fixture SA Ultra-Wide No Mount
Version Model NumberCET4R7007S
Company DUNS796083090
Company NameHIOSSEN, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814913029061 [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 Date2019-07-18
Device Publish Date2019-07-10

On-Brand Devices [ET IV Fixture SA Ultra-Wide No Mount]

00814913029108CET4R7013S
00814913029092CET4R7011S
00814913029085CET4R7010S
00814913029078CET4R7008S
00814913029061CET4R7007S
00814913029054CET4R6013S
00814913029047CET4R6011S
00814913029030CET4R6010S
00814913029023CET4R6008S
00814913029016CET4R6007S

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