ET O-ring Lab Analog (Regular)

GUDID 00810125999871

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810125999871
NIH Device Record Keyf0b4c9ad-8c09-4245-9f01-645d030fd417
Commercial Distribution StatusIn Commercial Distribution
Brand NameET O-ring Lab Analog (Regular)
Version Model NumberETOAL
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
GS100810125999871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDPAccessories, 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 Date2024-12-31
Device Publish Date2024-12-23

Devices Manufactured by HIOSSEN, INC.

00810125999703 - ET Stud abutment2024-12-31
00810125999710 - ET STUD ABUTMENT 2024-12-31
00810125999727 - ET STUD ABUTMENT 2024-12-31
00810125999734 - ET STUD ABUTMENT 2024-12-31
00810125999741 - ET STUD ABUTMENT 2024-12-31
00810125999758 - ET STUD ABUTMENT 2024-12-31
00810125999765 - ET STUD ABUTMENT 2024-12-31
00810125999772 - ET STUD ABUTMENT 2024-12-31

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