Home / 510(k) Clearances / K080514

510(k) K080514

PECD-01 AND PECD QUICK-01 by 3M Espe AG Dental Products — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2008
Date Received
February 25, 2008
Clearance Type
Special
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 Espe AG Dental Products

  • K100908 — UNICEM HM (June 22, 2010)
  • K100756 — MALTA (June 2, 2010)
  • K094007 — UNICEM (April 8, 2010)
  • K093721 — COSP2 (February 19, 2010)
  • K091826 — ELEGANT (September 25, 2009)
  • K090718 — BELLUS SHADING KIT (September 21, 2009)
  • K072055 — LAVA FRAME, LAVA FRAME SHADE (February 26, 2008)
  • K073296 — TEMPXN28 (January 9, 2008)
  • K071131 — UNO (July 25, 2007)
  • K071260 — HERMES BOND 3 (July 17, 2007)

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)