Polybone Dental

Q: When was Polybone Dental cleared by the FDA?

Polybone Dental (K092194) received a 510(k) decision of Substantially Equivalent on June 16, 2010, 330 days after the submission was received.

Q: What is the product code of K092194?

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) K092194 · Kyung Won Medical Co., Ltd.

Substantially Equivalent

510(k) numberK092194

Submission

Device name: Polybone Dental
Applicant: Kyung Won Medical Co., Ltd.
Santa Fe Springs, CA, US
Received: July 21, 2009
Decision date: June 16, 2010
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
K100373	Tyche Pedicle Screw SystemMNH · Traditional	06/30/2010SE
K082338	Polybone Granule & BlockMQV · Traditional	10/16/2008SE
K070012	PolyboneGXP · Traditional	12/27/2007SE

Questions and answers

When was Polybone Dental cleared by the FDA?

Polybone Dental (K092194) received a 510(k) decision of Substantially Equivalent on June 16, 2010, 330 days after the submission was received.

What is the product code of K092194?

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