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510(k) K883418

DE-BOND 200 by Scheu-Dental — Product Code EKS

K883418 is an FDA 510(k) premarket notification submitted by Scheu-Dental for the device "DE-BOND 200". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
August 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Pulp Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code EKS

  • K062856 — TF ROTARY NICKEL TITANIUM FILE (December 13, 2006)
  • K004031 — NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES (March 28, 2001)
  • K971319 — NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (May 22, 1997)
  • K970649 — HERO 642 (May 16, 1997)
  • K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES (June 4, 1996)
  • K953604 — SHAPING HEDSTROM N.T. (September 28, 1995)
  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 1994)
  • K932529 — LIGHTSPEED DENTAL HAND INSTRUMENT (November 4, 1993)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)

FDA data resources