ET ZIOCERA ABUTMENT

GUDID 00810019241093

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810019241093
NIH Device Record Keya6e4b052-7078-47ba-846d-f37184e43df7
Commercial Distribution StatusIn Commercial Distribution
Brand NameET ZIOCERA ABUTMENT
Version Model NumberETZCA555SHW
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810019241093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-23
Device Publish Date2019-05-15

On-Brand Devices [ET ZIOCERA ABUTMENT]

00810019241147ETZCA655SNW
00810019241130ETZCA655SHW
00810019241123ETZCA653SNW
00810019241116ETZCA653SHW
00810019241109ETZCA555SNW
00810019241093ETZCA555SHW
00810019241086ETZCA553SNW
00810019241079ETZCA553SHW
00810019241062ETZCA455SNW
00810019241055ETZCA455SHW
00810019241048ETZCA453SNW
00810019241031ETZCA453SHW
00810019241024ETZCA455MNW
00810019241017ETZCA455MHW
00810019241000ETZCA453MNW
00810019240997ETZCA453MHW

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