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510(k) K072309

MICROLUX/BLU by Addent, Inc. — Product Code EAZ

K072309 is an FDA 510(k) premarket notification submitted by Addent, Inc. for the device "MICROLUX/BLU". The FDA issued a decision of Substantially Equivalent on November 19, 2007. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Addent, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2007
Date Received
August 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Operating, Dental
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Addent, Inc.

  • K182017 — Compex HD (April 29, 2019)
  • K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN (July 24, 2012)
  • K082668 — BIO-SCREEN (January 23, 2009)
  • K062961 — MICROLUX TRANSILLUMINATOR (February 8, 2007)
  • K061395 — CALSET COMPOSITE HEATER (June 23, 2006)
  • K041614 — MICROLUX DL (April 4, 2005)

Other clearances for product code EAZ

  • K041614 — MICROLUX DL (April 4, 2005)
  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K935390 — SIROLUX FANTASTIC (December 10, 1993)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)
  • K902685 — DEFIANCE MODEL FUS 336 (September 17, 1990)

FDA data resources