EK Healing Abutment

GUDID 00810019245428

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810019245428
NIH Device Record Keyd9ec30fa-e981-414c-b4fa-87d7f6700fe8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK Healing Abutment
Version Model NumberEKHA406
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810019245428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-22
Device Publish Date2022-02-14

On-Brand Devices [EK Healing Abutment]

00810019245695EKHA805
00810019245688EKHA709
00810019245671EKHA707
00810019245664EKHA706
00810019245657EKHA705
00810019245640EKHA704
00810019245633EKHA703
00810019245626EKHA609
00810019245619EKHA607
00810019245602EKHA606
00810019245596EKHA605
00810019245589EKHA604
00810019245572EKHA603
00810019245565EKHA509
00810019245558EKHA507
00810019245541EKHA506
00810019245534EKHA505
00810019245527EKHA504
00810019245510EKHA503
00810019245503EKHA459
00810019245497EKHA457
00810019245480EKHA456
00810019245473EKHA455
00810019245466EKHA454
00810019245459EKHA453
00810019245442EKHA409
00810019245435EKHA407
00810019245428EKHA406
00810019245411EKHA405
00810019245404EKHA404
00810019245398EKHA403

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