SM7 US ( Complete Set )

GUDID 00810126043153

SM7 complete set - The SM7 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: 00810126043153
• NIH Device Record Key: 514e94d0-0d9d-4f08-a44d-aec094e24606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SM7 US ( Complete Set )
• Version Model Number: Y1500891U
• 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	00810126043153 [Primary]

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: 2026-01-19
• Device Publish Date: 2026-01-09

Devices Manufactured by HIOSSEN, INC.

• 00810126043153 - SM7 US ( Complete Set ): 2026-01-19SM7 complete set - The SM7 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.
• 00810126043153 - SM7 US ( Complete Set ): 2026-01-19 SM7 complete set - The SM7 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used w
• 00810126043160 - S200EML (Contra) Dental Surgery Hand Piece: 2026-01-19 S200EML (Contra) is intended for use in dental oral surgery and dental implant. The dental handpieces fitted with appropriate to
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• 00810126043511 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07
• 00810126043528 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043580 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07