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510(k) K082668

BIO-SCREEN by Addent, Inc. — Product Code NXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2009
Date Received
September 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diagnostic Light, Soft Tissue Detector
Device Class
Class II
Regulation Number
872.6350
Review Panel
DE
Submission Type

To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities

Other clearances by Addent, Inc.

  • K182017 — Compex HD (April 29, 2019)
  • K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN (July 24, 2012)
  • K072309 — MICROLUX/BLU (November 19, 2007)
  • K062961 — MICROLUX TRANSILLUMINATOR (February 8, 2007)
  • K061395 — CALSET COMPOSITE HEATER (June 23, 2006)
  • K041614 — MICROLUX DL (April 4, 2005)

Other clearances for product code NXV

  • K151630 — G.o.c.c.l.e.s. (September 15, 2015)
  • K123169 — ORALID (March 13, 2013)
  • K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN (July 24, 2012)
  • K102083 — VELSCOPE VX (November 18, 2010)
  • K101140 — DENTLIGHT ORAL EXAM LIGHT KIT (July 15, 2010)
  • K090135 — TRIMIRA IDENTAFI 3000 (February 17, 2009)
  • K082603 — TRIMIRA OCS 3000 (December 12, 2008)
  • K080043 — VIZILITE EYEWEAR (April 4, 2008)
  • K073483 — SAPPHIRE O/E ORAL EXAMINATION SYSTEM (April 3, 2008)
  • K070523 — MODIFICATION TO: VELSCOPE (April 5, 2007)