ZCORE™ EXPAND

GUDID D765ZXSINUSL0

Expandable Collagen-Enriched Porcine Xenograft (Large Sinus), 12 mm x 17 mm

Osteogenics Biomedical Inc

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• Primary Device ID: D765ZXSINUSL0
• NIH Device Record Key: a7063f98-01a0-40d7-ab84-ad984fff7e3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZCORE™ EXPAND
• Version Model Number: ZXSINUSL
• Company DUNS: 123853058
• Company Name: Osteogenics Biomedical 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: false
• Manufacturing Date: false
• 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 Dimensions

• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter
• Width: 17 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D765ZXSINUSL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202183

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-05
• Device Publish Date: 2021-06-25

On-Brand Devices [ZCORE™ EXPAND]

• D765ZXSOCKET0: Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm
• D765ZXSINUSS0: Expandable Collagen-Enriched Porcine Xenograft (Small Sinus), 10 mm x 13 mm
• D765ZXSINUSL0: Expandable Collagen-Enriched Porcine Xenograft (Large Sinus), 12 mm x 17 mm