Home / 510(k) Clearances / K926368

510(k) K926368

APPLICATOR NOZZLE by Centrix, Inc. — Product Code EKJ

K926368 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "APPLICATOR NOZZLE". The FDA issued a decision of Substantially Equivalent on September 15, 1993. The device falls under product code EKJ (Burnisher, Operative), 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
September 15, 1993
Date Received
December 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
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 EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)

FDA data resources