ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Dent4you AG, Osstem Implant Co., Ltd. and B&E Korea Co., Ltd..

402

Total

402

Cleared

95d

Avg days

1976

Since

Declining activity - 5 submissions in the last 2 years vs 7 in the prior period

Consistent review times: 91d avg (recent)

FDA 510(k) Cleared Material, Impression Devices (Product Code ELW)

402 devices

1–24 of 402

1 2 3 4

Cleared Mar 19, 2026

Dia-X Sil Bite

K254112

DiaDent Group International

Dental · 90d

Cleared Oct 31, 2025

Hydro Print Premium Fast Set - 454g (1lb) (052037)

K253501

Vigodent Ind?stria E Comercio Ltda

Elastic Impression Material

K241924

Beijing Okvd Biological Technology , Ltd.

Chemi-SiL (HB, MB, LB, LBS)

HySil Plus Impression Materials

K210041

Osstem Implant Co., Ltd.

Dental · 70d

1 2 3 4

About Product Code ELW - Regulatory Context

510(k) Submission Activity

402 total 510(k) submissions under product code ELW since 1976, with 402 receiving FDA clearance (average review time: 95 days).

Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 7 in the prior period.

FDA Review Time

FDA review times for ELW submissions have been consistent, averaging 91 days recently vs 95 days historically.

ELW devices are reviewed by the Dental panel. Browse all Dental devices →