EK Freeform ST Abutment 4.0(3.0), Hex

GUDID 00810019248849

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019248849
• NIH Device Record Key: c311b8c8-1c1c-4e79-a284-924f0b8289d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK Freeform ST Abutment 4.0(3.0), Hex
• Version Model Number: EKFA4030TH
• 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	00810019248849 [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

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