POLYVINYL SILICONE IMPRESSION MATERIAL— 510(k) K810825

Name: FDA 510(k) clearance K810825
Creator: U.S. Food and Drug Administration
Published: 1981-04-14

Substantially Equivalent

Dental-Material Gesellschaft

FDA 510(k) clearance K810825 for POLYVINYL SILICONE IMPRESSION MATERIAL, Substantially Equivalent on 1981-04-14. Applicant: Dental-Material Gesellschaft. Device class: 2.

Clearance details

Applicant: Dental-Material Gesellschaft
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1981-03-24
Decision date: 1981-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

view all

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
K241924 — Elastic Impression Material2024-12-27
K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator2024-11-15

More clearances from Dental-Material Gesellschaft

view all

K810813 — DMG-POLISHABLE COMPOSITE1981-04-14

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