FDA product code · Dental · Class 2
LYC: Bone Grafting Material, Synthetic
LYC is FDA's product code for "Bone Grafting Material, Synthetic": a Class 2 device classified under 21 CFR 872.3930, reviewed by the Dental panel. FDA flags it as an implant.
510(k) review time for LYC
Across 11 510(k) clearances under LYC decided from 2018-01-01 to 2026-10-06, the median was 267 days from FDA receipt to decision. Half took between 213 and 315 days, and 80% were decided within 332 days. These are past clearances, not a forecast for a new submission.
| Fastest | 115 |
|---|---|
| 25th percentile | 213 |
| Median | 267 |
| 75th percentile | 315 |
| 80th percentile | 332 |
| 90th percentile | 456 |
| Slowest | 535 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
LYC in the public FDA record
| 510(k) clearances, all years | 231 |
|---|---|
| Device recalls | 14 |
| Establishment listings | 189 |
| GUDID device identifiers | 1,032 |
Counts of records, not of devices or events. Adverse event reports for LYC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite LYC
1 FDA recognized consensus standard cite LYC, among them ANSI ADA Standard No. 206-2024. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-332 ANSI ADA Standard No. 206-2024 — Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.