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510(k) K896693

FLEXI-CAST CROWN CORE SYSTEM by Essential Dental Systems, Inc. — Product Code ELR

K896693 is an FDA 510(k) premarket notification submitted by Essential Dental Systems, Inc. for the device "FLEXI-CAST CROWN CORE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 14, 1990. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Essential Dental Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1990
Date Received
November 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
Review Panel
DE
Submission Type

Other clearances by Essential Dental Systems, Inc.

  • K223340 — EDS Calculus Softener TURBO CR (December 11, 2023)
  • K202281 — EDS Bioceramic Sealer (Bioseal) (February 12, 2021)
  • K152691 — EDS Universal Cement (February 25, 2016)
  • K140846 — EDS COMBO-RINSE (July 25, 2014)
  • K132609 — EDS ULTRASONIC TIPS (January 22, 2014)
  • K111541 — ENDO-EXPRESS (R) HANDPIECE (March 16, 2012)
  • K101504 — TI-CORE FLOW (October 29, 2010)
  • K072555 — EDTA PLUS (December 13, 2007)
  • K070401 — ENDO-CHX (July 11, 2007)
  • K063856 — EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM (February 6, 2007)

Other clearances for product code ELR

  • K060075 — FIBER-METAL POST (March 30, 2006)
  • K042848 — FRC POSTEC PLUS (November 22, 2004)
  • K030820 — EVERSTICK POST (May 20, 2003)
  • K020431 — FIBIOCORE (July 3, 2002)
  • K012496 — CARBON POST (May 17, 2002)
  • K013802 — FRC POSTEC (May 1, 2002)
  • K012849 — GLASS POST (March 27, 2002)
  • K012354 — SNOWPOST, SNOWLIGHT (October 10, 2001)
  • K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (October 25, 2000)

FDA data resources