LONE STAR IMPRESSION SYSTEMS— 510(k) K980968

Name: FDA 510(k) clearance K980968
Creator: U.S. Food and Drug Administration
Published: 1998-06-09

Substantially Equivalent

Lone Star Technologies

FDA 510(k) clearance K980968 for LONE STAR IMPRESSION SYSTEMS, Substantially Equivalent on 1998-06-09. Applicant: Lone Star Technologies. Device class: 2.

Clearance details

Applicant: Lone Star Technologies
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1998-03-16
Decision date: 1998-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatham, NJ, 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 Lone Star Technologies

view all

K981234 — FLARE,FILE, FILL1998-06-05

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