EK Freeform ST Abutment 5.0(1.5), Non-hex

GUDID 00810019248894

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019248894
• NIH Device Record Key: a7f94d00-85c6-4702-9e68-5a58bf3caba9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK Freeform ST Abutment 5.0(1.5), Non-hex
• Version Model Number: EKFA5015NTH
• 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: false
• 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	00810019248894 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-31
• Device Publish Date: 2022-05-23

Devices Manufactured by HIOSSEN, INC.

• 00810126043245 - ETIII SA (Ø3.2mm) Pre-mounted: 2025-10-07
• 00810126043481 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043504 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043511 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07
• 00810126043528 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043580 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07
• 00810126043597 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043603 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07