EK NP-CAST ABUTMENT

GUDID 00810019249143

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

• Primary Device ID: 00810019249143
• NIH Device Record Key: dcf63c05-6deb-4d75-9baa-2386a4824493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK NP-CAST ABUTMENT
• Version Model Number: EKNA4510NTH
• 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	00810019249143 [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

On-Brand Devices [EK NP-CAST ABUTMENT]

• 00810019249174: EKNA4530TH
• 00810019249167: EKNA4530NTH
• 00810019249150: EKNA4510TH
• 00810019249143: EKNA4510NTH
• 00810019249136: EKNA4030TH
• 00810019249129: EKNA4030NTH
• 00810019249112: EKNA4010TH
• 00810019249105: EKNA4010NTH