EK Hybrid Zirconia Abutment

GUDID 00810125999260

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810125999260
NIH Device Record Key2633c9b4-f8ea-4340-b170-693f9202211b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK Hybrid Zirconia Abutment
Version Model NumberEKHZ4041ONT
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
GS100810125999260 [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 Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [EK Hybrid Zirconia Abutment]

00810125999536EKHZ4544ONT
00810125999697EKHZ4564CNT
00810125999680EKHZ4563CNT
00810125999673EKHZ4562CNT
00810125999666EKHZ4561CNT
00810125999659EKHZ4564CHT
00810125999642EKHZ4563CHT
00810125999635EKHZ4562CHT
00810125999628EKHZ4561CHT
00810125999611EKHZ4544CNT
00810125999604EKHZ4543CNT
00810125999598EKHZ4542CNT
00810125999581EKHZ4541CNT
00810125999574EKHZ4544CHT
00810125999567EKHZ4543CHT
00810125999550EKHZ4542CHT
00810125999543EKHZ4541CHT
00810125999529EKHZ4542ONT
00810125999512EKHZ4542ONT
00810125999505EKHZ4541ONT
00810125999499EKHZ4544OHT
00810125999482EKHZ4543OHT
00810125999475EKHZ4542OHT
00810125999468EKHZ4541OHT
00810125999451EKHZ4064CNT
00810125999444EKHZ4063CNT
00810125999437EKHZ4062CNT
00810125999420EKHZ4061CNT
00810125999413EKHZ4064CHT
00810125999406EKHZ4063CHT
00810125999390EKHZ4062CHT
00810125999383EKHZ4061CHT
00810125999376EKHZ4044CNT
00810125999369EKHZ4043CNT
00810125999352EKHZ4042CNT
00810125999345EKHZ4041CNT
00810125999338EKHZ4044CHT
00810125999321EKHZ4043CHT
00810125999314EKHZ4042CHT
00810125999307EKHZ4041CHT
00810125999291EKHZ4044ONT
00810125999284EKHZ4043ONT
00810125999277EKHZ4042ONT
00810125999260EKHZ4041ONT
00810125999253EKHZ4044OHT
00810125999246EKHZ4043OHT
00810125999239EKHZ4042OHT
00810125999222EKHZ4041OHT

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