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510(k) K822620

ROOT CANAL REAMERS, TYPE K by Union Broach, Div. Moyco Industries, Inc. — Product Code EKP

K822620 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "ROOT CANAL REAMERS, TYPE K". The FDA issued a decision of Substantially Equivalent on September 28, 1982. The device falls under product code EKP (Reamer, Pulp Canal, 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
September 28, 1982
Date Received
August 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer, 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)
  • 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 EKP

  • K823686 — REAMER TYPE K ENDODONTIC (December 28, 1982)
  • K800291 — ENDEX REAMERS PULP CANAL, ENDODONTIC (February 19, 1980)
  • K770331 — DIALYSIS, JET SYSTEM (April 20, 1977)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)
  • K770367 — ROOT CANAL FILES & REAMERS (March 1, 1977)

FDA data resources