Dental Porous Morsels 2x0.5g EU0820

GUDID 00813909010328

Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

Dental bone matrix implant, synthetic

• Primary Device ID: 00813909010328
• NIH Device Record Key: 1e173ee8-1aa5-4a53-bb54-a530a844b8fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Porous Morsels 2x0.5g
• Version Model Number: EU0820
• Catalog Number: EU0820
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, LLC
• Device Count: 2
• 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

• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909010328 [Primary]
GS1	00813909013749 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112428

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2025-07-25
• Device Publish Date: 2025-07-17

Devices Manufactured by NOVABONE PRODUCTS, LLC

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• 00813909013770 - IRM - 2.5cc: 2025-08-12 Synthetic bone void filler for orthopedic applications
• 00813909013787 - IRM - 5.0cc: 2025-08-12 Synthetic bone void filler for orthopedic applications
• 00813909010328 - Dental Porous Morsels 2x0.5g: 2025-07-25Synthetic bone void filler for dental applications
• 00813909010328 - Dental Porous Morsels 2x0.5g: 2025-07-25 Synthetic bone void filler for dental applications
• 00813909013756 - Dental Porous Morsels 2x1.5g: 2025-07-25 Synthetic bone void filler for dental applications
• 00813909013701 - Bioactive Strip 10.0cc Long: 2025-07-17 Synthetic bone void filler for orthopedic applications
• 00813909013718 - IRM - 2.5cc: 2025-07-17 Synthetic bone void filler for orthopedic applications
• 00813909013725 - IRM - 5.0cc: 2025-07-17 Synthetic bone void filler for orthopedic applications