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510(k) K823489

ENDODONTIC BROACH-BARBED BROACH by Union Broach, Div. Moyco Industries, Inc. — Product Code EKW

K823489 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "ENDODONTIC BROACH-BARBED BROACH". The FDA issued a decision of Substantially Equivalent on December 15, 1982. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Union Broach, Div. Moyco Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1982
Date Received
November 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Broach, 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)
  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 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)

Other clearances for product code EKW

  • K871493 — DENTI-TRAY(TM) (June 24, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K862523 — MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS (August 1, 1986)
  • K831749 — ENDODONTIC BROACH(76EKN) BARBED BROACH (July 12, 1983)
  • K800292 — ENDEX BROACH, ENDODONTIC (February 19, 1980)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)

FDA data resources