Home / 510(k) Clearances / K945142

510(k) K945142

POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) by Scican — Product Code ELW

K945142 is an FDA 510(k) premarket notification submitted by Scican for the device "POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)". The FDA issued a decision of Substantially Equivalent on January 11, 1995. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Scican has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1995
Date Received
October 20, 1994
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 Scican

  • K214057 — STATIM 6000B Vacuum Autoclave (March 31, 2022)
  • K210326 — Bravo G4 Chamber Autoclave (July 1, 2021)
  • K192910 — STATClave G4 Chamber Autoclave (June 19, 2020)
  • K190062 — STATCLAVE G4 Chamber Autoclave (July 26, 2019)
  • K172292 — SALUS - Hygiene Instrument Reprocessing Container (November 24, 2017)
  • K132356 — SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST (January 31, 2014)
  • K112872 — STATIM 2000 G4 CASSETTE (July 10, 2012)
  • K090937 — E-STATIS 40 SYSTEM (July 24, 2009)
  • K090265 — BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V (May 15, 2009)
  • K073319 — STATMATIC 31 HANDPIECE MAINTENANCE UNIT (February 4, 2008)

Other clearances for product code ELW

  • K254112 — Dia-X Sil Bite (March 19, 2026)
  • 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)

FDA data resources