HySil Impression Materials— 510(k) K170736

Name: FDA 510(k) clearance K170736
Creator: U.S. Food and Drug Administration
Published: 2017-06-07

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K170736 for HySil Impression Materials, Substantially Equivalent on 2017-06-07. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2017-03-10
Decision date: 2017-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

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 Osstem Implant Co., Ltd.

view all

K251434 — Healing Abutment System2026-03-04
K251569 — Bone Screw2025-08-13
K242521 — Estar-ZE2024-11-20
K233806 — T2 Plus2024-09-06
K233194 — TS Abutment System2024-02-20

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