FDA product code · Dental · Class 2
LBH: Varnish, Cavity
LBH is FDA's product code for "Varnish, Cavity": a Class 2 device classified under 21 CFR 872.3260, reviewed by the Dental panel.
510(k) review time for LBH
Across 23 510(k) clearances under LBH decided from 2018-01-01 to 2026-10-06, the median was 229 days from FDA receipt to decision. Half took between 86 and 280 days, and 80% were decided within 301 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 86 |
| Median | 229 |
| 75th percentile | 280 |
| 80th percentile | 301 |
| 90th percentile | 344 |
| Slowest | 427 |
| Year | Median days | n |
|---|---|---|
| 2020 | 256 | 5 |
| 2026 (to 10-06, partial) | 64 | 5 |
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.
LBH in the public FDA record
| 510(k) clearances, all years | 139 |
|---|---|
| Device recalls | 9 |
| Establishment listings | 190 |
| GUDID device identifiers | 1,016 |
Counts of records, not of devices or events. Adverse event reports for LBH 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 LBH
3 FDA recognized consensus standards cite LBH, 2 of them recognized only in part, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO 17730 Second edition 2020-09; ISO 17730 Third edition 2025-09. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-319 ISO 17730 Second edition 2020-09 (partial recognition) — Dentistry - Fluoride varnishes
- 4-354 ISO 17730 Third edition 2025-09 (partial recognition) — Dentistry - Fluoride varnishes
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.