Home / 510(k) Clearances / K801380

510(k) K801380

CROWN DELTA SILICONE IMPRESSION MATERIAL by Crown Delta Corp. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
June 11, 1980
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 Crown Delta Corp.

  • K122974 — TRYOUT-VPS HOLDING PASTE (May 17, 2013)
  • K041028 — CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL (May 14, 2004)
  • K955288 — HEARING AID IMPRESSION MATERIAL (February 2, 1996)
  • K940132 — PODIATRIC MATERIAL (September 29, 1994)
  • K930248 — VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM (January 7, 1994)
  • K926150 — VINYL ADDITION SILICONE SYSTEM (July 14, 1993)
  • K901990 — VINYL SILICONE ELASTOMER MATERIAL (September 14, 1990)
  • K901991 — SILICONE ELASTOMER PUTTY (September 14, 1990)
  • K872745 — VINYL POLYSILOXANE IMPRESSION SYSTEM (July 21, 1987)
  • K871409 — VINYL POLYSILOXANE IMPRESSION SYSTEM (June 11, 1987)

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)