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510(k) K823489

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

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

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  • K935542 — NICKEL-TITANIUM K-TYPE FILE (January 3, 1994)
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  • 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)