HySil Plus Impression Materials— 510(k) K210041

Name: FDA 510(k) clearance K210041
Creator: U.S. Food and Drug Administration
Published: 2021-03-18

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K210041 for HySil Plus Impression Materials, Substantially Equivalent on 2021-03-18. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2021-01-07
Decision date: 2021-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

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 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.