FDA product code LYC: Bone Grafting Material, Synthetic
LYC is the FDA product code for bone grafting material, synthetic. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. FDA has cleared 231 510(k) submissions under LYC, 8 in the last five years, from 117 different applicants. The average 510(k) review took 169 days (median 104); 256 days on average over the last three years. FDA has posted 14 recalls for LYC devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Bone Grafting Material, Synthetic |
| Device class | Class II |
| Regulation | 21 CFR 872.3930 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LYC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 3 | 201 |
| 2022 | 2 | 496 |
| 2025 | 3 | 277 |
| 2026 | 3 | 235 |
Compare with all 510(k) review times · Search every LYC clearance
Top LYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Interfaces, Inc. | 15 | 1996-04-10 |
| Ceramed Corp. | 13 | 1996-08-20 |
| Geistlich-Pharma | 11 | 2002-03-28 |
| Novabone Products, LLC | 9 | 2011-12-16 |
| Interpore Intl. | 6 | 1997-10-30 |
112 more applicants have LYC clearances. See the full list in Caduvo.
Most recent LYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253317 | GC America, Inc. | Cytrans Elashield | 2026-07-06 | 279 |
| K253883 | Bonalive , Ltd. | Bonalive Maxillofacial | 2026-05-14 | 161 |
| K251818 | Hudens Bio Co., Ltd. | BONTREE PLUS | 2026-03-06 | 266 |
| K244006 | Full Golden Biotech Co., Ltd. | FG Bone Graft M | 2025-09-17 | 265 |
| K243745 | Full Golden Biotech Corporation | FG Bone Graft B | 2025-08-29 | 267 |
Recalls for LYC devices
14 product recalls in 11 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LYC?
LYC is the FDA product code for bone grafting material, synthetic. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.
What device class is LYC?
Class II, regulation 21 CFR 872.3930. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYC?
Across 231 cleared submissions the average was 169 days from receipt to decision (median 104).
Which companies have the most LYC clearances?
Bio-Interfaces, Inc. (15); Ceramed Corp. (13); Geistlich-Pharma (11); Novabone Products, LLC (9); Interpore Intl. (6).
Have LYC devices been recalled?
Yes: 14 product recalls across 11 recall events; the most recent began 2018-08-16.
Next steps
- Run an FDA pathway report with predicate devices for product code LYC
- Run a recall and safety report across every LYC manufacturer
- Watch product code LYC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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