SMARTFIT FINAL HYBRID DENTURE - 5

GUDID 00810126042019

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810126042019
• NIH Device Record Key: 6509aba1-0d69-4fc1-a054-40f3e98ed019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTFIT FINAL HYBRID DENTURE - 5
• Version Model Number: FNLHYD05
• 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	00810126042019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171585

FDA Product Code

• NDP: Accessories, 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: 2025-04-09
• Device Publish Date: 2025-04-01

Devices Manufactured by HIOSSEN, INC.

• 00810126043269 - ETIII SA (Ø3.2mm) Pre-mounted: 2025-10-01
• 00810126043535 - ET III Fixture SA Regular Pre-Mounted: 2025-10-01
• 00810126043542 - ET III Fixture NH Regular Pre-Mounted: 2025-10-01
• 00810126043559 - ET III Fixture SA Regular Pre-Mounted: 2025-10-01
• 00810126043566 - ET III Fixture SA Regular Pre-Mounted: 2025-10-01
• 00810126043573 - ET III Fixture NH Regular Pre-Mounted: 2025-10-01
• 00810126043191 - SMARTFIT PROVISONAL DENTURE: 2025-08-05
• 00810126043207 - SMARTFIT TRY IN HYBRID DENTURE - No Hole: 2025-08-05