EM Provisional

GUDID 00810019243585

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019243585
• NIH Device Record Key: 88035889-4140-4035-8685-4d988e813437
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM Provisional
• Version Model Number: EMT18104
• 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	00810019243585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191751

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: 2020-03-20
• Device Publish Date: 2020-03-12

On-Brand Devices [EM Provisional]

• 00810019243639: EMT25154
• 00810019243622: EMT25134
• 00810019243615: EMT25104
• 00810019243608: EMT18154
• 00810019243592: EMT18134
• 00810019243585: EMT18104