Osferion D

Q: When was Osferion D cleared by the FDA?

Osferion D (K081561) received a 510(k) decision of Substantially Equivalent on July 28, 2008, 55 days after the submission was received.

Q: What is the product code of K081561?

The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.

FDA 510(k) K081561 · Olympus Terumo Biomaterials Corporation

Substantially Equivalent

510(k) numberK081561

Submission

Device name: Osferion D
Applicant: Olympus Terumo Biomaterials Corporation
Center Valley, PA, US
Received: June 3, 2008
Decision date: July 28, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LYC – Bone Grafting Material, Synthetic
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3930
Specialty: Dental
Implant: Yes

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.

Other 510(k)s with product code LYC

510(k)	Device	Applicant	Decision
K253317	Cytrans ElashieldLYC · Traditional	GC America, Inc.	07/06/2026SE
K253883	Bonalive MaxillofacialLYC · Special	Bonalive , Ltd.	05/14/2026SE
K251818	Bontree PlusLYC · Traditional	Hudens Bio Co., Ltd.	03/06/2026SE
K244006	FG Bone Graft MLYC · Traditional	Full Golden Biotech Co., Ltd.	09/17/2025SE
K243745	FG Bone Graft BLYC · Traditional	Full Golden Biotech Corporation	08/29/2025SE
K241186	Synthetic Bone Graft ParticulateLYC · Traditional	Shenzhen Dazhou Medical Technology Co., Ltd.	02/21/2025SE
K213260	CMFlexTMLYC · Traditional	Dimension Inx Corp.	12/30/2022SE
K202675	InRoad® Dental Synthetic Bone GraftLYC · Traditional	Osteogene Tech Corp	03/04/2022SE
K201546	OsOpia Synthetic Bone Void FillerLYC · Traditional	Revisios BV	10/02/2020SE
K201051	Straumann BoneCeramicLYC · Traditional	Institut Straumann AG	09/24/2020SE

More from Institut Straumann AG

510(k)	Device	Decision
K111087	FoundationLYC · Traditional	11/29/2011SE
K080065	OsferionMQV · Traditional	05/02/2008SE

Questions and answers

When was Osferion D cleared by the FDA?

Osferion D (K081561) received a 510(k) decision of Substantially Equivalent on July 28, 2008, 55 days after the submission was received.

What is the product code of K081561?

The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.