Foundation®

FDA UDI

Class II (US FDA UDI)

by Olympus Terumo Biomaterials Corporation

Identity

Trade Name: Foundation® FDA UDI
Generic Name: Dental bone matrix implant, animal-derived FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 27-500-100 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 27-500-100 FDA UDI
Primary DI / UDI-DI: 04560245656821 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: Dental bone matrix implant, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 25 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI

Category: Dental bone matrix implant, animal-derived

Foundation® by Olympus Terumo Biomaterials Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olympus Terumo Biomaterials Corporation

Sources (1)

FDA UDI 8cea1c11-bca4-4d82-947e-4a1e85892574 38 fields · synced May 30, 2026