SMARTFIT FINAL HYBRID DENTURE - 4

GUDID 00810126042002

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810126042002
• NIH Device Record Key: 4ad14f7b-bc4d-4c9f-a544-dba1f16f5d0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTFIT FINAL HYBRID DENTURE - 4
• Version Model Number: FNLHYD04
• 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	00810126042002 [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.

• 00810126041425 - ET Healing Abutment Mini, 4.3(D), 6.0(H): 2025-04-09
• 00810126041432 - ET Healing Abutment Regular, 4.3(D), 6.0(H): 2025-04-09
• 00810126041449 - ET Healing Abutment Mini, 4.8(D), 6.0(H): 2025-04-09
• 00810126041456 - ET Healing Abutment Regular, 4.8(D), 6.0(H): 2025-04-09
• 00810126041463 - ET Healing Abutment Regular, 5.3(D), 6.0(H): 2025-04-09
• 00810126041470 - ET Healing Abutment Regular, 6.3(D), 6.0(H): 2025-04-09
• 00810126041487 - ET Healing Abutment Regular, 7.3(D), 6.0(H): 2025-04-09
• 00810126041494 - ET cover screw Mini: 2025-04-09