ET GOLDCAST ABUTMENT

GUDID 00814913028514

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913028514
NIH Device Record Keya398daf1-955c-477d-9003-5c675c8eada8
Commercial Distribution StatusIn Commercial Distribution
Brand NameET GOLDCAST ABUTMENT
Version Model NumberETGCA403MNW
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
GS100814913028514 [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 Date2019-05-23
Device Publish Date2019-05-15

On-Brand Devices [ET GOLDCAST ABUTMENT]

00814913028552ETGCA453SNW
00814913028545ETGCA453SHW
00814913028538ETGCA451SNW
00814913028521ETGCA451SHW
00814913028514ETGCA403MNW
00814913028507ETGCA403MHW
00814913028491ETGCA401MNW
00814913028484ETGCA401MHW

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