SM3

GUDID 00814913029603

SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

HIOSSEN, INC.

Dental implant system

• Primary Device ID: 00814913029603
• NIH Device Record Key: 29859777-d8d1-43c3-bd94-f26946528454
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SM3
• Version Model Number: SM3 120V OPT
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814913029603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173905

FDA Product Code

• EBW: Controller, Foot, Handpiece And Cord

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: 2021-01-28
• Device Publish Date: 2021-01-20

Devices Manufactured by HIOSSEN, INC.

• 00810125999703 - ET Stud abutment: 2024-12-31
• 00810125999710 - ET STUD ABUTMENT: 2024-12-31
• 00810125999727 - ET STUD ABUTMENT: 2024-12-31
• 00810125999734 - ET STUD ABUTMENT: 2024-12-31
• 00810125999741 - ET STUD ABUTMENT: 2024-12-31
• 00810125999758 - ET STUD ABUTMENT: 2024-12-31
• 00810125999765 - ET STUD ABUTMENT: 2024-12-31
• 00810125999772 - ET STUD ABUTMENT: 2024-12-31