FDA product code · Dental · Class U
LFD: Saliva, Artificial
LFD is FDA's product code for "Saliva, Artificial": a Class U device, reviewed by the Dental panel.
510(k) review time for LFD
Across 16 510(k) clearances under LFD decided from 2018-01-01 to 2026-10-06, the median was 142 days from FDA receipt to decision. Half took between 96 and 282 days, and 80% were decided within 287 days. These are past clearances, not a forecast for a new submission.
| Fastest | 58 |
|---|---|
| 25th percentile | 96 |
| Median | 142 |
| 75th percentile | 282 |
| 80th percentile | 287 |
| 90th percentile | 324 |
| Slowest | 498 |
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.
LFD in the public FDA record
| 510(k) clearances, all years | 50 |
|---|
Counts of records, not of devices or events. Adverse event reports for LFD 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 LFD
3 FDA recognized consensus standards cite LFD, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12; ANSI ADA Standard No. 116-2020; ISO 28888 First edition 2013-10. 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
- 4-287 ANSI ADA Standard No. 116-2020 — Oral Rinses (Modified adoption of ISO 16408:2015 Dentistry Oral Care Products -Oral Rinses)
- 4-292 ISO 28888 First edition 2013-10 — Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.