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

• 00813909012919 - Porous Wedge 20%: 2024-07-18 Synthetic bone void filler for orthopedic applications
• 00813909012926 - Porous Wedge 35%: 2024-07-18 Synthetic bone void filler for orthopedic applications
• 00813909012933 - Bioactive Strip 5.0cc: 2024-07-05 Synthetic bone void filler for orthopedic applications
• 00813909012940 - MacroPor-Si+ 8.0 cc: 2024-07-05 Synthetic bone void filler for orthopedic applications
• 00813909012957 - Putty Syringe 5.0cc: 2024-07-05 Synthetic bone void filler for orthopedic applications
• 00813909012964 - Putty Syringe 10.0cc: 2024-07-05 Synthetic bone void filler for orthopedic applications
• 00813909012971 - Putty Syringe 2.5cc: 2024-07-05 Synthetic bone void filler for orthopedic applications
• 00813909012889 - IRM 2.5cc: 2024-06-05 Synthetic bone void filler for orthopedic applications