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510(k) K940260

THERMAL PULP TESTER by Union Broach, Div. Moyco Industries, Inc. — Product Code EAT

K940260 is an FDA 510(k) premarket notification submitted by Union Broach, Div. Moyco Industries, Inc. for the device "THERMAL PULP TESTER". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Union Broach, Div. Moyco Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
January 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pulp
Device Class
Class II
Regulation Number
872.1720
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)
  • 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)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)
  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K011666 — CHILLIT (August 6, 2001)
  • K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED (February 25, 1999)
  • K973439 — ENDO ANALYZER, MODEL 8005 (December 8, 1997)
  • K970715 — SYSTEM B HEAT SOURCE (April 7, 1997)
  • K963862 — TOUCH N' HEAT (December 2, 1996)
  • K960799 — ORTHO-ICE (May 9, 1996)
  • K950237 — DIGITEST (June 9, 1995)

FDA data resources