ET O-ring Retainer Set

GUDID 00810125999840

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810125999840
NIH Device Record Key9b97a386-cdbc-42bc-8511-6e3b909fdb84
Commercial Distribution StatusIn Commercial Distribution
Brand NameET O-ring Retainer Set
Version Model NumberETRS01
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
GS100810125999840 [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.

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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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