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510(k) K792461

CENTRIX MKIV ENDODONTIC DELIVERY by Centrix, Inc. — Product Code EIC

K792461 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "CENTRIX MKIV ENDODONTIC DELIVERY". The FDA issued a decision of Substantially Equivalent on December 19, 1979. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. Centrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1979
Date Received
December 3, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Periodontic, Endodontic, Irrigating
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Centrix, Inc.

  • K250714 — FluoroDose Varnish (November 21, 2025)
  • K222459 — Centrix FluoroSilver Silver Diamine Fluoride 38% (October 27, 2023)
  • K152826 — NoCord (May 27, 2016)
  • K140144 — BENDA WEDGE (July 8, 2014)
  • K120176 — SENZZZZZ AWAY (July 25, 2012)
  • K111348 — RE / STASIS (TM) GINGIVAL RETRACTION PASTE (July 22, 2011)
  • K092384 — LIQUICORD (November 4, 2009)
  • K091380 — CORDCAP (July 30, 2009)
  • K021131 — CHLORAPREP (September 26, 2002)
  • K021146 — D/SENSE 1-STEP (July 2, 2002)

Other clearances for product code EIC

  • K972234 — RCT GEL ROOT CANAL THERAPY GEL (June 30, 1997)
  • K864307 — MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) (November 18, 1986)
  • K861846 — HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (June 26, 1986)
  • K851944 — MAX-I-PROBE HANDPIECE (July 1, 1985)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K811889 — R & S SERIES FITTING TOOLS (July 24, 1981)
  • K811594 — WATER PISTOL (July 15, 1981)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K792578 — EPIC CANNULA (January 4, 1980)

FDA data resources