ET ZIOCERA ANGLED ABUTMENT

GUDID 00810019241185

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810019241185
NIH Device Record Key2d2e9a8d-7bfa-450a-add6-cd26df003c43
Commercial Distribution StatusIn Commercial Distribution
Brand NameET ZIOCERA ANGLED ABUTMENT
Version Model NumberETZAA654SNW
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
GS100810019241185 [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 ANGLED ABUTMENT]

00810019241185ETZAA654SNW
00810019241178ETZAA654SHW
00810019241161ETZAA553SNW
00810019241154ETZAA553SHW

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