ET Gold Cast Abutment SET

GUDID 00810125994371

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810125994371
NIH Device Record Key12a009e1-3de7-4cfc-a7ea-ff14dddca021
Commercial Distribution StatusIn Commercial Distribution
Brand NameET Gold Cast Abutment SET
Version Model NumberETGA4010SCWH
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
GS100810125994371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, 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 Date2024-07-15
Device Publish Date2024-07-05

On-Brand Devices [ET Gold Cast Abutment SET]

00810125994449ETGA4530BCWH
00810125994432ETGA4530SCWH
00810125994425ETGA4510BCWH
00810125994418ETGA4510SCWH
00810125994401ETGA4030BCWH
00810125994395ETGA4030SCWH
00810125994388ETGA4010BCWH
00810125994371ETGA4010SCWH

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