Home / 510(k) Clearances / K120438

510(k) K120438

FLASH (DIFFERENT MATERIALS) by 3M Deutschland GmbH — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
February 13, 2012
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 3M Deutschland GmbH

  • K220257 — Permadyne (February 1, 2022)
  • K192992 — Suglue 3 (November 5, 2019)
  • K192961 — ADH19 (October 31, 2019)
  • K173318 — Rapid HB, Rapid LB, Rapid MB (October 31, 2017)
  • K161922 — XP202 (September 1, 2016)
  • K153174 — Ketac Universal Aplicap (April 13, 2016)
  • K151748 — Clean & More (March 11, 2016)
  • K151144 — SuPro 100 (September 14, 2015)
  • K140684 — CLINPRO PROPHY POWDER (October 24, 2014)
  • K133436 — FLASH AR; FLASH AR QUICK (March 7, 2014)

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)