ET STUD ABUTMENT

GUDID 00810125999741

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810125999741
NIH Device Record Key4803a1e6-3794-4de6-aea8-a16c8e83d2fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameET STUD ABUTMENT
Version Model NumberETSAO353M
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
GS100810125999741 [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 Date2024-12-31
Device Publish Date2024-12-23

On-Brand Devices [ET STUD ABUTMENT ]

00810125995514ETSA3560C
00810125995507ETSA3550C
00810125995491ETSA3540C
00810125995484ETSA3530C
00810125995477ETSA3520C
00810125995460ETSA3510C
00810125995453ETSAM3560C
00810125995446ETSAM3550C
00810125995439ETSAM3540C
00810125995422ETSAM3530C
00810125995415ETSAM3520C
00810125995408ETSAM3510C
00810125999819ETSAO356S
00810125999802ETSAO356M
00810125999796ETSAO355S
00810125999789ETSAO355M
00810125999772ETSAO354S
00810125999765ETSAO354M
00810125999758ETSAO353S
00810125999741ETSAO353M
00810125999734ETSAO352S
00810125999727ETSAO352M
00810125999710ETSAO351S
00810125999703ETSAO351M

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