Collagen
Foundation® - 27-500-100
Device Description
A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
Environmental Conditions
- 30.00
- N/A
- 86.00
- N/A
Device Sizes
- Length: 25 Millimeter
- Outer Diameter: 8 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LYC
Device Name: Bone Grafting Material, Synthetic
Device Class: 2
Physical State: N/A
Definition: A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Submission Type ID: 1
Review Panel: DE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 872.3930
Third Party Flag: N
Medical Specialty: DE
Device Identifiers
Device Id: 14560245656828
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04560245656821
Package Quantity: 10
Package Discontinue Date: 2/28/2026 12:00:00 AM
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 04560245656821
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
