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510(k) K931742

INJECT-R FILL by Union Broach, Div. Moyco Industries, Inc. — Product Code EKM

K931742 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "INJECT-R FILL". The FDA issued a decision of Substantially Equivalent on May 27, 1993. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Union Broach, Div. Moyco Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
April 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gutta-Percha
Device Class
Class I
Regulation Number
872.3850
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)
  • 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 EKM

  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070246 — DOWN PAK (February 16, 2007)
  • K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (June 26, 2006)
  • K042870 — ENDO TWINN (January 11, 2005)
  • K023819 — FIBERFILL SGP (March 26, 2003)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)
  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)
  • K910224 — THERMAPREP (March 29, 1991)

FDA data resources