ET FREEFORM ST ABUTMENT

GUDID 00810019240812

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810019240812
NIH Device Record Keycd119b9c-df7c-4737-beae-8eae5b9fc547
Commercial Distribution StatusIn Commercial Distribution
Brand NameET FREEFORM ST ABUTMENT
Version Model NumberETFSA403SHW
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
GS100810019240812 [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 FREEFORM ST ABUTMENT]

00810019240980ETFSA703SNW
00810019240973ETFSA703SHW
00810019240966ETFSA701SNW
00810019240959ETFSA701SHW
00810019240942ETFSA603SNW
00810019240935ETFSA603SHW
00810019240928ETFSA601SNW
00810019240911ETFSA601SHW
00810019240904ETFSA503SNW
00810019240898ETFSA503SHW
00810019240881ETFSA501SNW
00810019240874ETFSA501SHW
00810019240867ETFSAS503SNW
00810019240850ETFSAS503SHW
00810019240843ETFSAS501SNW
00810019240836ETFSAS501SHW
00810019240829ETFSA403SNW
00810019240812ETFSA403SHW
00810019240805ETFSA401SNW
00810019240799ETFSA401SHW
00810019240782ETFSA403MNW
00810019240775ETFSA403MHW
00810019240768ETFSA401MNW
00810019240751ETFSA401MHW

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