HYUNJAE DENTAL IMPRESSION MATERIALS— 510(k) K962680

Name: FDA 510(k) clearance K962680
Creator: U.S. Food and Drug Administration
Published: 1996-09-30

Substantially Equivalent

Hyunjae Corp.

FDA 510(k) clearance K962680 for HYUNJAE DENTAL IMPRESSION MATERIALS, Substantially Equivalent on 1996-09-30. Applicant: Hyunjae Corp.. Device class: 2.

Clearance details

Applicant: Hyunjae Corp.
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1996-07-10
Decision date: 1996-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Milford, CT, 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 Hyunjae Corp.

view all

K973927 — HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL1997-12-11

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