LYCClass II

Bone Grafting Material, Synthetic

21 CFR 872.3930 / Dental

LYC is the FDA product code for Bone Grafting Material, Synthetic, a class II device type, regulated under 21 CFR 872.3930. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 231 510(k) clearances under this code, the most recent dated 2026-07-06, and 14 recalls.

Classification record

Product code: LYC
Device name: Bone Grafting Material, Synthetic
FDA definition: 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.
Regulation: 21 CFR 872.3930
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 231
Ingested recalls: 14

Clearances, product code LYC

By decision year

231 clearances under product code LYC with a decision year between 1979 and 2026, 1996 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code LYC by decision year
Year	Clearances
1979	1
1981	3
1982	2
1983	2
1984	7
1985	6
1986	8
1987	2
1988	2
1989	2
1990	1
1991	2
1992	4
1993	5
1994	6
1995	13
1996	15
1997	6
1998	7
1999	4
2000	8
2001	12
2002	3
2003	5
2004	11
2005	9
2006	7
2007	13
2008	8
2009	14
2010	13
2011	9
2012	5
2013	2
2014	1
2016	2
2020	3
2022	2
2025	3
2026	3

Applicants with the most clearances

Product code LYC

Applicants holding the most 510(k) clearances under product code LYC
Applicant	Clearances
Bio-Interfaces, Inc.	15
Ceramed Corp.	13
Geistlich Pharma AG	11
Novabone Products, LLC	9
Unicare Biomedical, Inc.	7
Coors Biomedical Co.	6
Interpore Intl.	6
W. L. Gore & Associates, Inc.	5
Etex Corp.	4
GENOSS Co., Ltd.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 83 companies shown, in name order