Dental Putty Cartridge 4 x 0.25cc ND4640

GUDID 00813909013572

Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

Dental bone matrix implant, synthetic

• Primary Device ID: 00813909013572
• NIH Device Record Key: a5f18314-25ca-4ff7-8f4e-df3b6f220cf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Putty Cartridge 4 x 0.25cc
• Version Model Number: ND4640
• Catalog Number: ND4640
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, LLC
• Device Count: 4
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909013510 [Primary]
GS1	00813909013572 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100671

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: 2025-05-05
• Device Publish Date: 2025-04-25

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• 00813909013183 - Porous Morsels 1-2mm 10.0cc: 2025-07-01 Synthetic bone void filler for orthopedic applications
• 00813909013190 - Bioactive Strip 5.0cc: 2025-07-01 Synthetic bone void filler for orthopedic applications
• 00813909013206 - MacroPor-Si+ 8.0 cc: 2025-07-01 Synthetic bone void filler for orthopedic applications
• 00813909013213 - Putty Syringe 10.0cc: 2025-07-01 Synthetic bone void filler for orthopedic applications
• 00813909013220 - Putty Syringe 2.5cc: 2025-07-01 Synthetic bone void filler for orthopedic applications