Home / 510(k) Clearances / K201184

510(k) K201184

Lascod Impression Materials by Lascod Spa — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2020
Date Received
May 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Lascod Spa

  • K121824 — ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 (August 23, 2012)

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)