SMARTFIT FINAL HYBRID DENTURE -No Hole

GUDID 00810126043214

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810126043214
• NIH Device Record Key: 81809986-d4ef-4299-b2f8-0b2f8a7f9d44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTFIT FINAL HYBRID DENTURE -No Hole
• Version Model Number: FNLHYD00
• 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	00810126043214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171585

FDA Product Code

• EIH: Powder, Porcelain

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: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by HIOSSEN, INC.

• 00810126043191 - SMARTFIT PROVISONAL DENTURE: 2025-08-05
• 00810126043207 - SMARTFIT TRY IN HYBRID DENTURE - No Hole: 2025-08-05
• 00810126043214 - SMARTFIT FINAL HYBRID DENTURE -No Hole: 2025-08-05
• 00810126043214 - SMARTFIT FINAL HYBRID DENTURE -No Hole: 2025-08-05
• 00810126042101 - Bite Impression Coping Driver: 2025-05-06
• 00810126042118 - Bite Impression Coping Driver: 2025-05-06
• 00810126042736 - ET Bite Impression Coping: 2025-05-02
• 00810126042095 - ET O-Ring Retainer Cap: 2025-04-25
• 00810126042125 - ET FIXTURE PICK-UP IMPRESSION COPING: 2025-04-25