ET III Fixture NH Mini No Mount

GUDID 00810126044372

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126044372
NIH Device Record Key40199bbc-30ee-4a41-8b69-e557704978d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III Fixture NH Mini No Mount
Version Model NumberCET3M3513B
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
GS100810126044372 [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 Fixture NH Mini No Mount]

00810126044396CET3M3515B
00810126044372CET3M3513B
00810126044358CET3M3511B
00810126044334CET3M3510B
00810126044310CET3M3508B

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