FDA product code · Dental · Class 2
ELW: Material, Impression
ELW is FDA's product code for "Material, Impression": a Class 2 device classified under 21 CFR 872.3660, reviewed by the Dental panel.
510(k) review time for ELW
Across 31 510(k) clearances under ELW decided from 2018-01-01 to 2026-10-06, the median was 100 days from FDA receipt to decision. Half took between 66 and 171 days, and 80% were decided within 246 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 66 |
| Median | 100 |
| 75th percentile | 171 |
| 80th percentile | 246 |
| 90th percentile | 318 |
| Slowest | 478 |
| Year | Median days | n |
|---|---|---|
| 2018 | 126 | 5 |
| 2022 | 60 | 7 |
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.
ELW in the public FDA record
| 510(k) clearances, all years | 402 |
|---|---|
| Device recalls | 14 |
| Establishment listings | 661 |
| GUDID device identifiers | 4,803 |
Counts of records, not of devices or events. Adverse event reports for ELW 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 ELW
8 FDA recognized consensus standards cite ELW, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12; ISO 4823 Fifth edition 2021-02; ANSI ADA Standard No. 41-2020. 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
- 4-278 ISO 4823 Fifth edition 2021-02 — Dentistry - Elastomeric impression and bite registration materials
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- 4-301 ISO 21563 Second edition 2021-08 — Dentistry - Hydrocolloid impression materials
- 4-365 ISO 6873 Third edition 2013-04 — Dentistry - Gypsum products
- 4-368 ISO 4823 Sixth edition 2025-06 — Dentistry - Elastomeric impression and bite registration materials
- 4-372 ANSI ADA Standard No. 141-2013 (R2023) — Dentistry-Dental Duplicating Material
- 4-388 ISO 14356 Second edition 2024-10 — Dentistry - Duplicating material
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.