A-Oss®A-graft®[Bone grafting material,Animal source]

GUDID 00814913025018

HIOSSEN, INC.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00814913025018
• NIH Device Record Key: 3e463a71-ecc0-44bb-a662-4c7bce270f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A-Oss®A-graft®[Bone grafting material,Animal source]
• Version Model Number: HAS200SV
• 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: true
• 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	00814913025018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151542

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-03
• Device Publish Date: 2018-04-27

Devices Manufactured by HIOSSEN, INC.

• 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
• 00810126043245 - ETIII SA (Ø3.2mm) Pre-mounted: 2025-10-07
• 00810126043481 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043504 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 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