ET III Fixture SA Mini No Mount

GUDID 00810126044402

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126044402
NIH Device Record Key44d2b677-cdec-45ce-bbfa-7963b08f3cf9
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III Fixture SA Mini No Mount
Version Model NumberCET3M3515S
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
GS100810126044402 [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 SA Mini No Mount]

00814913021003CET3M3515S
00814913020990CET3M3513S
00814913020983CET3M3511S
00814913020976CET3M3510S
00814913020969CET3M3508S
00810126044402CET3M3515S
00810126044389CET3M3513S
00810126044365CET3M3511S
00810126044341CET3M3510S
00810126044327CET3M3508S

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