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

Devices Manufactured by NOVABONE PRODUCTS, LLC

• 00813909013329 - Dental Putty Syringe 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013336 - Dental Putty Syringe 1.0cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013343 - Dental Putty Syringe 2.0cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013350 - Dental Cartridge Dispenser: 2025-05-05 Dispenser used with synthetic bone void filler for dental applications
• 00813909013558 - Dental Putty Cartridge 2 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013565 - Dental Putty Cartridge 6 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013527 - PerioGlas - 2 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013534 - PerioGlas 6 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications