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510(k) K101140

DENTLIGHT ORAL EXAM LIGHT KIT by Dentlight, Inc. — Product Code NXV

K101140 is an FDA 510(k) premarket notification submitted by Dentlight, Inc. for the device "DENTLIGHT ORAL EXAM LIGHT KIT". The FDA issued a decision of Substantially Equivalent on July 15, 2010. The device falls under product code NXV (Diagnostic Light, Soft Tissue Detector), a Class II device regulated under 21 CFR 872.6350. Dentlight, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2010
Date Received
April 22, 2010
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 Dentlight, Inc.

  • K201387 — Ultrafast, Ultrafast Plus, Ultrafast Lite (February 26, 2021)
  • K180065 — FUSION Plus Curing Light (April 19, 2019)
  • K052593 — FUSION CURING LIGHT (September 28, 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)
  • K090135 — TRIMIRA IDENTAFI 3000 (February 17, 2009)
  • K082668 — BIO-SCREEN (January 23, 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)

FDA data resources