Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of absorbable atelo-collagen. The atelo-collagen has been cross-linked by heat treatment in order to achieve biocompatibility. FOUNDATION is provided in bullet shapes. The collagen (liquid form) suspension is pored into a bullet shape mold. The design of the bullet shape is to permit easy placement into the extraction socket. It consists of fibrillar and heat-denatured atelo-collagen. Fibrillar atelo-collagen provides scaffolding for surrounding cells and the heat-denatured atelo-collagen stimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.

Collagen
Foundation® - 27-500-100

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.

• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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