Ossaplast Dental (Particle Size of 500 to 1000 Um to 2000 Um)

Q: What is the product code of K053374?

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) K053374 · Ossacur AG

Substantially Equivalent

510(k) numberK053374

Submission

Device name: Ossaplast Dental (Particle Size of 500 to 1000 Um to 2000 Um)
Applicant: Ossacur AG
Santa Barbara, CA, US
Received: December 5, 2005
Decision date: February 21, 2006
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 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
K051047	Colloss E Bone Void FillerMQV · Traditional	03/08/2006SE
K050416	Ossaplast OrthoMQV · Abbreviated	03/29/2005SE
K042305	Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901…MQV · Abbreviated	10/21/2004SE

Questions and answers

When was Ossaplast Dental (Particle Size of 500 to 1000 Um to 2000 Um) cleared by the FDA?

Ossaplast Dental (Particle Size of 500 to 1000 Um to 2000 Um) (K053374) received a 510(k) decision of Substantially Equivalent on February 21, 2006, 78 days after the submission was received.

What is the product code of K053374?

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