MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)— 510(k) K041229

Name: FDA 510(k) clearance K041229
Creator: U.S. Food and Drug Administration
Published: 2004-06-17

Substantially Equivalent

Cosmedent, Inc.

FDA 510(k) clearance K041229 for MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL), Substantially Equivalent on 2004-06-17. Applicant: Cosmedent, Inc.. Device class: 2.

Clearance details

Applicant: Cosmedent, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2004-05-10
Decision date: 2004-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

view all

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Cosmedent, Inc.

view all

K240714 — Insure® Universal; Insure® Universal Automix2024-07-24
K222435 — Renamel® Microhybrid; Renamel® Flowable Microhybrid2022-10-11
K211259 — Renamel Bulkfill2021-06-24
K172707 — Renamel Microfill2017-12-05
K163480 — Renamel NANO +plus2017-02-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.