EK Onefit Abutment(Gold)

GUDID 00810125999178

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

Primary Device ID	00810125999178
NIH Device Record Key	69ff5570-9f04-4889-93dc-a963574ab959
Commercial Distribution Status	In Commercial Distribution
Brand Name	EK Onefit Abutment(Gold)
Version Model Number	EKCMAHCT
Company DUNS	796083090
Company Name	HIOSSEN, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810125999178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K233389

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-06-25
Device Publish Date	2024-06-17

On-Brand Devices [EK Onefit Abutment(Gold)]

00810125999185	EKCMANCT
00810125999178	EKCMAHCT