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510(k) K935542

NICKEL-TITANIUM K-TYPE FILE by Union Broach, Div. Moyco Industries, Inc. — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1994
Date Received
November 16, 1993
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 Union Broach, Div. Moyco Industries, Inc.

  • K962733 — CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) (October 11, 1996)
  • K950365 — MOYCO-EDTA (April 27, 1995)
  • K941574 — RETRO MIRROR (May 18, 1994)
  • K940260 — THERMAL PULP TESTER (March 7, 1994)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K923661 — QUADRASORB FILTER (October 20, 1992)
  • K895174 — UNION BROACH BLEACHING LIGHT (April 13, 1990)
  • K855136 — FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE (March 6, 1986)
  • K852474 — UNION BROACH BLEACHING LIGHT (July 1, 1985)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)

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)
  • K932529 — LIGHTSPEED DENTAL HAND INSTRUMENT (November 4, 1993)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K902018 — DENTAURUM CERAMIC DEBONDING UNIT (April 3, 1991)
  • K905640 — SOLID CORE GUTTA PERCHA CARRIER (March 5, 1991)