EM SA IMPLANT (NARROW RIDGE)

GUDID 00810019242694

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019242694
• NIH Device Record Key: 383ccf9a-0b37-44e5-94f6-d0270f8b7554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM SA IMPLANT (NARROW RIDGE)
• Version Model Number: EMN2508S40
• 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	00810019242694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191201

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2019-12-27
• Device Publish Date: 2019-12-19

On-Brand Devices [EM SA IMPLANT (NARROW RIDGE)]

• 00810019242878: EMN3015S40
• 00810019242861: EMN3015S25
• 00810019242854: EMN3013S40
• 00810019242847: EMN3013S25
• 00810019242830: EMN3011S40
• 00810019242823: EMN3011S25
• 00810019242816: EMN3010S40
• 00810019242809: EMN3010S25
• 00810019242793: EMN3008S40
• 00810019242786: EMN3008S25
• 00810019242779: EMN2515S40
• 00810019242762: EMN2515S25
• 00810019242755: EMN2513S40
• 00810019242748: EMN2513S25
• 00810019242731: EMN2511S40
• 00810019242724: EMN2511S25
• 00810019242717: EMN2510S40
• 00810019242700: EMN2510S25
• 00810019242694: EMN2508S40
• 00810019242687: EMN2508S25