EK RIGID ABUTMENT

GUDID 00810019245831

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810019245831
NIH Device Record Key653215ee-503a-42af-9531-def97bf36cb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK RIGID ABUTMENT
Version Model NumberEKRA4621P
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
GS100810019245831 [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 Date2022-05-31
Device Publish Date2022-05-23

On-Brand Devices [EK RIGID ABUTMENT]

00810019246340EKRA7650P
00810019246333EKRA7640P
00810019246326EKRA7630P
00810019246319EKRA7620P
00810019246302EKRA7610P
00810019246296EKRA6750P
00810019246272EKRA6730P
00810019246265EKRA6720P
00810019246258EKRA6710P
00810019246241EKRA6650P
00810019246234EKRA6640P
00810019246227EKRA6630P
00810019246210EKRA6620P
00810019246203EKRA6610P
00810019246197EKRA6450P
00810019246180EKRA6440P
00810019246173EKRA6430P
00810019246166EKRA6420P
00810019246159EKRA6410P
00810019246142EKRA5750P
00810019246135EKRA5740P
00810019246128EKRA5730P
00810019246111EKRA5720P
00810019246104EKRA5710P
00810019246098EKRA5650P
00810019246081EKRA5640P
00810019246074EKRA5630P
00810019246067EKRA5620P
00810019246050EKRA5610P
00810019246043EKRA5450P
00810019246036EKRA5440P
00810019246029EKRA5430P
00810019246012EKRA5420P
00810019246005EKRA5410P
00810019245992EKRA4751P
00810019245985EKRA4750P
00810019245978EKRA4741P
00810019245961EKRA4740P
00810019245954EKRA4731P
00810019245947EKRA4730P
00810019245930EKRA4721P
00810019245923EKRA4720P
00810019245916EKRA4711P
00810019245909EKRA4710P
00810019245893EKRA4651P
00810019245886EKRA4650P
00810019245879EKRA4641P
00810019245862EKRA4640P
00810019245855EKRA4631P
00810019245848EKRA4630P

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