ET III NH Ultra-Wide Fixture Pre-Mounted

GUDID 00810126044099

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126044099
NIH Device Record Keyb8aaa81f-f0ee-43c1-9f81-aa8138756922
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III NH Ultra-Wide Fixture Pre-Mounted
Version Model NumberAET3R7006B
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
GS100810126044099 [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 Date2025-10-07
Device Publish Date2025-09-29

On-Brand Devices [ET III NH Ultra-Wide Fixture Pre-Mounted]

00810126044198AET3R7013B
00810126044174AET3R7011B
00810126044150AET3R7010B
00810126044136AET3R7008B
00810126044112AET3R7007B
00810126044099AET3R7006B
00810126044075AET3R6013B
00810126044051AET3R6011B
00810126044037AET3R6010B
00810126044013AET3R6008B
00810126043993AET3R6007B
00810126043979AET3R6006B

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