MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL— 510(k) K905032

Name: FDA 510(k) clearance K905032
Creator: U.S. Food and Drug Administration
Published: 1991-03-15

Substantially Equivalent

Parkell

FDA 510(k) clearance K905032 for MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL, Substantially Equivalent on 1991-03-15. Applicant: Parkell. Device class: 2.

Clearance details

Applicant: Parkell
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1990-11-07
Decision date: 1991-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, 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 Parkell

view all

K923867 — METAFIL1992-10-06
K900303 — CONNECT1990-04-12
K896719 — PRIMER-P ADHESIVE AGENT1990-02-22
K895750 — HEMA-PRIMER1989-12-21
K892003 — ABRAKADABRA - DENTAL ADHESIVE SYSTEM1989-06-07

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