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510(k) K864922

DENTAL HANDPIECES AND ATTACHMENT by E&D Dental Manufacturing Co. — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1987
Date Received
December 16, 1986
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 by E&D Dental Manufacturing Co.

  • K883698 — ZINC OXIDE EUGENOL TEMPORARY CEMENT (November 29, 1988)
  • K873739 — ACRYLIC IMPRESSION TRAY MATERIALS (March 7, 1988)
  • K873738 — ACRYLIC BASE DENTURE MATERIALS (November 20, 1987)
  • K871639 — DENTAL DIAMOND BURS (May 18, 1987)
  • K862745 — EUGENOL USP (July 31, 1986)

Other clearances for product code EKS

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  • 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)