EM SA IMPLANT (DENTURE)

GUDID 00810019242670

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019242670
• NIH Device Record Key: f10af9f2-f87f-435b-b169-d510f7de78b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM SA IMPLANT (DENTURE)
• Version Model Number: EMD3015S40
• 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	00810019242670 [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 (DENTURE)]

• 00810019242670: EMD3015S40
• 00810019242663: EMD3015S20
• 00810019242656: EMD3013S40
• 00810019242649: EMD3013S20
• 00810019242632: EMD3011S40
• 00810019242625: EMD3011S20
• 00810019242618: EMD3010S40
• 00810019242601: EMD3010S20
• 00810019242595: EMD3008S40
• 00810019242588: EMD3008S20
• 00810019242571: EMD2515S40
• 00810019242564: EMD2515S20
• 00810019242557: EMD2513S40
• 00810019242540: EMD2513S20
• 00810019242533: EMD2511S40
• 00810019242526: EMD2511S20
• 00810019242519: EMD2510S40
• 00810019242502: EMD2510S20
• 00810019242496: EMD2508S40
• 00810019242489: EMD2508S20
• 00810019242472: EMD2015S40
• 00810019242465: EMD2015S20
• 00810019242458: EMD2013S40
• 00810019242441: EMD2013S20
• 00810019242434: EMD2011S40
• 00810019242427: EMD2011S20
• 00810019242410: EMD2010S40
• 00810019242403: EMD2010S20
• 00810019242397: EMD2008S40
• 00810019242380: EMD2008S20