Home / 510(k) Clearances / K192941

510(k) K192941

HySil Super Fast Impression Materials by Osstem Implant Co., Ltd. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2020
Date Received
October 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Osstem Implant Co., Ltd.

  • K251434 — Healing Abutment System (March 4, 2026)
  • K251569 — Bone Screw (August 13, 2025)
  • K242521 — Estar-ZE (November 20, 2024)
  • K233806 — T2 Plus (September 6, 2024)
  • K233194 — TS Abutment System (February 20, 2024)
  • K232220 — SS Abutment System (December 5, 2023)
  • K232012 — N1 (November 28, 2023)
  • K222778 — Osstem Implant System (September 23, 2023)
  • K221684 — Osstem Abutment System (September 8, 2022)
  • K212303 — T2 (September 21, 2021)

Other clearances for product code ELW

  • K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular (October 31, 2025)
  • K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (June 27, 2025)
  • K241924 — Elastic Impression Material (December 27, 2024)
  • K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex U (November 15, 2024)
  • K233954 — Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (February 13, 2024)
  • K223892 — DentMix VPS Impression Material (April 27, 2023)
  • K213175 — No Stress Impress (January 19, 2023)
  • K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impres (December 15, 2022)
  • K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(R (November 7, 2022)
  • K213244 — Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Ac (September 9, 2022)