Dental Porous Morsels 2x1.5g NA0822

GUDID 00813909012285

Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

Dental bone matrix implant, synthetic

• Primary Device ID: 00813909012285
• NIH Device Record Key: 470f5227-7396-431b-92a9-1711194847f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Porous Morsels 2x1.5g
• Version Model Number: NA0822
• Catalog Number: NA0822
• 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: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram
• Weight: 1.5 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909012285 [Unit of Use]
GS1	00813909012292 [Primary]

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: 2021-04-14
• Device Publish Date: 2021-04-06

Devices Manufactured by NOVABONE PRODUCTS, LLC

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• 00813909013114 - Putty Syringe 2.5cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013121 - Putty Syringe 5.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013138 - Putty Syringe 10.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013145 - IRM - 5.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909012988 - Dispenser MIS Cartridge: 2024-08-29 Dispenser used with synthetic bone void filler for orthopedic applications
• 00813909012995 - Putty MIS System 10.0cc: 2024-08-29 Synthetic bone void filler for orthopedic applications
• 00813909013091 - Putty MIS System 10.0cc: 2024-08-29 Synthetic bone void filler for orthopedic applications