EK Healing Abutment

GUDID 00810019245671

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 Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019245671
• NIH Device Record Key: f7e835fb-de67-4fdf-89e8-4482dd0c2168
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK Healing Abutment
• Version Model Number: EKHA707
• 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	00810019245671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203360

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-22
• Device Publish Date: 2022-02-14

On-Brand Devices [EK Healing Abutment]

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