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Foundation Bone Grafting Material, Synthetic

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111087

by Olympus Terumo Biomaterials Corporation

Identifiers

510(k) Number
K111087 FDA 510(k)
FDA Product Code
LYC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Foundation is a synthetic bone grafting material classified as a collagen-based absorbable plug. It is designed as a sponge-like substance intended for filling extraction sockets and promoting bone regeneration in dental procedures. This material is composed of atelo-collagen, a purified form of collagen derived from natural sources, which supports tissue integration and bone growth while gradually resorbing over time.

Supplied as a sterile, single-use device, the Foundation is intended for use in dental settings. It is packaged to maintain sterility and is regulated under FDA 510(k) clearance (K111087) as a Class II device under regulation 872.3930. The material is non-magnetic and does not contain components that would interfere with MRI safety. Storage instructions are not specified in the data, but standard sterile storage conditions apply.

Frequently asked questions

What is the Foundation bone grafting material used for?

The Foundation is designed as a collagen-based absorbable plug to fill dental extraction sockets. Its sponge-like structure supports tissue integration and bone regeneration while gradually resorbing over time, making it ideal for procedures where maintaining socket stability and promoting new bone growth are critical.

Is the Foundation plug single-use or reusable?

The Foundation is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintains the material’s integrity for optimal performance in dental procedures.

What material is the Foundation plug made from?

The Foundation is composed of atelo-collagen, a purified form of collagen derived from natural sources. This material is biocompatible and supports tissue integration and bone growth without interfering with MRI safety.

How should the Foundation plug be stored?

While specific storage instructions aren’t detailed in the data, standard sterile storage conditions apply. This means keeping the packaging intact and storing it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and effectiveness.

What regulatory clearance does the Foundation have?

The Foundation is cleared under FDA 510(k) (K111087) as a Class II device under regulation 872.3930. This classification indicates it has been deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for dental bone grafting applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Submitter: I<I O 7FOUNDATION Olympus Terumo Biomaterials Corp ..., OLYMPUS TERUMO BIOMATERIALS CORPORATION - fda.report, Olympus-Terumo-Biomaterials-Corp FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Terumo Biomaterials Corporation

Sources (1)

  • FDA 510(k) K111087 24 fields · synced Oct 1, 2026