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510(k) K861581

CENTRIX PCR MOLAR MATRIX FORMS (BANDS) by Centrix, Inc. — Product Code DZN

K861581 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "CENTRIX PCR MOLAR MATRIX FORMS (BANDS)". The FDA issued a decision of Substantially Equivalent on May 12, 1986. The device falls under product code DZN (Instruments, Dental Hand), 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
May 12, 1986
Date Received
April 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Dental Hand
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 DZN

  • K111465 — COMPOTHIXO (July 25, 2012)
  • K071858 — DENTAL MATRIX BAND (August 31, 2007)
  • K901919 — CONTACT MOLAR BANDS AND CONTOUR STRIPS (June 22, 1990)
  • K844324 — TIGER BAND (December 3, 1984)
  • K840984 — INTERDENTAL WEDGES (April 13, 1984)
  • K822094 — DENTAL MATRIX BAND (August 16, 1982)
  • K821444 — COLORED WEDGE USED TO SEPARATE TEETH (June 14, 1982)
  • K801142 — PALODENT MATRICES & BITINE RINGS (August 7, 1980)
  • K801530 — COREFORM MOLDS (July 28, 1980)
  • K790555 — HEMO-WEDGE (January 17, 1980)

FDA data resources