FDA product code · Dental
LYCBone Grafting Material, Synthetic
Product code LYC covers Bone Grafting Material, Synthetic, a Class II device regulated under 21 CFR 872.3930. FDA has cleared 231 devices in this code, 5 of them in the last 12 months. Median review time across the 231 most recent decisions is 104 days. openFDA lists 14 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3930
- Review panel
- Dental
- Clearances
- 231
What is happening in LYC right now?
LYC (Bone Grafting Material, Synthetic) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Bonalive , Ltd. and Hudens Bio Co., Ltd (K253883, K251818, K243745). The code is crowded, scoring 80 of 100 — 107 companies hold a clearance here and 5 arrived in the last 12 months (LYC:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253883, K251818, K243745 |
| Crowding | Context | LYC:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code LYC cover?
LYC is FDA's product code for Bone Grafting Material, Synthetic, a Class II device regulated under 21 CFR 872.3930.
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.
Source: openFDA device/classification · record LYC · retrieved
How many devices has FDA cleared in LYC?
FDA has cleared 231 devices under product code LYC since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253317 | Cytrans Elashield | GC America, Inc. | |
| K253883 | Bonalive Maxillofacial | Bonalive , Ltd. | |
| K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | |
| K213260 | CMFlexTM | Dimension Inx Corp. | |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | |
| K201051 | Straumann BoneCeramic | Institut Straumann AG |
How long does FDA review take for LYC?
The median FDA review time for LYC is 104 days, measured across the 231 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LYC?
openFDA lists 14 recall records against product code LYC. A recall record covers one firm's corrective action and may span many device lots.
Z-0414-2019TerminatedCollagen Matrix, Inc.
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Z-0113-2017TerminatedOsteogenics Biomedical, Inc.
The device has the potential to be packaged in the wrong product box.
Z-0788-2016TerminatedBiomet France SARL
Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
Z-1233-2014TerminatedBiomet 3i, LLC
Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
Z-1298-2013TerminatedIntegra LifeSciences Corporation
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Showing the 5 most recently initiated of 14. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LYC?
MAUDE holds 15 adverse-event reports naming product code LYC, 1 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LYC unusual?
LYC does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 5 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
7 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered LYC in the last year?
3 companies filed in LYC for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Bonalive , Ltd. | K253883 | |
| Hudens Bio Co., Ltd. | K251818 | |
| Full Golden Biotech Corporation | K243745 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in LYC?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LYC?
Across the 231 most recent decisions, these applicants filed most often in LYC.
| Applicant | Recent clearances |
|---|---|
| Bio-Interfaces, Inc. | 15 |
| Ceramed Corp. | 13 |
| Geistlich-Pharma | 11 |
| Novabone Products, LLC | 9 |
| Coors Biomedical Co. | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in LYC files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Unicare Biomedical, Inc. | 7 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch LYC
Get an email the morning anything changes in LYC — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.