S & C VINYL POLYSILOXANE IMPRESSION MATERIAL— 510(k) K951075

Name: FDA 510(k) clearance K951075
Creator: U.S. Food and Drug Administration
Published: 1995-03-31

Substantially Equivalent

S & C Polymer GmbH

FDA 510(k) clearance K951075 for S & C VINYL POLYSILOXANE IMPRESSION MATERIAL, Substantially Equivalent on 1995-03-31. Applicant: S & C Polymer GmbH. Device class: 2.

Clearance details

Applicant: S & C Polymer GmbH
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1995-03-09
Decision date: 1995-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

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 S & C Polymer GmbH

view all

K091735 — DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT2009-09-25
K083062 — ROOT CANAL XR2009-03-12
K083766 — PHOGLASS CEM2009-03-02
K082115 — PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT2009-01-15
K081702 — CARBOXYLATE CEM, PHOSPHATE CEM2008-09-05

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