ET III SA Ultra-Wide Fixture No Mount

GUDID 00810126045102

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126045102
NIH Device Record Keye3558ce9-ce7b-45d2-a16f-01cb972f9cb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III SA Ultra-Wide Fixture No Mount
Version Model NumberCET3R7010S
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
GS100810126045102 [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 SA Ultra-Wide Fixture No Mount]

00814913024967CET3R7013S
00814913024950CET3R7011S
00814913024943CET3R7010S
00814913024936CET3R7008S
00814913024929CET3R7007S
00814913024912CET3R7006S
00814913024905AET3R6013S
00814913024899CET3R6011S
00814913024882CET3R6010S
00814913024875CET3R6008S
00814913024868CET3R6007S
00814913024851CET3R6006S
00810126045140CET3R7013S
00810126045126CET3R7011S
00810126045102CET3R7010S
00810126045089CET3R7008S
00810126045065CET3R7007S
00810126045041CET3R7006S
00810126045027CET3R6013S
00810126045003CET3R6011S
00810126044983CET3R6010S
00810126044969CET3R6008S
00810126044945CET3R6007S
00810126044921CET3R6006S

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