Dentoridge(Tm) Hydroxyylapatite

Q: What is the product code of K882098?

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) K882098 · Norian Corp.

Substantially Equivalent

510(k) numberK882098

Submission

Device name: Dentoridge(Tm) Hydroxyylapatite
Applicant: Norian Corp.
Menlo Park, CA, US
Received: May 19, 1988
Decision date: June 13, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K983104	Norian Periodontal/Dental Cement (PDC)LYC · Traditional	02/12/1999SE
K973789	Norian Cranial Repair System (Crs)Bone Cement- 5CC Kit, Norian Cranial Repair System…GXP · Traditional	05/18/1998SE

Questions and answers

When was Dentoridge(Tm) Hydroxyylapatite cleared by the FDA?

Dentoridge(Tm) Hydroxyylapatite (K882098) received a 510(k) decision of Substantially Equivalent on June 13, 1988, 25 days after the submission was received.

What is the product code of K882098?

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