Home / 510(k) Clearances / K102821

510(k) K102821

DISCOVRED by Phoenix Dental, Inc. — Product Code LFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2011
Date Received
September 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Caries Detection
Device Class
Class II
Regulation Number
872.1740
Review Panel
DE
Submission Type

Other clearances by Phoenix Dental, Inc.

  • K120109 — SUPER SEAL TOOTH DESENSITIZER (March 7, 2012)
  • K983477 — SUPER SEAL (December 22, 1998)
  • K926101 — PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO (June 23, 1994)
  • K926102 — PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN (June 22, 1994)

Other clearances for product code LFC

  • K222560 — BlueCheck™ Caries Detection & Monitoring (May 16, 2023)
  • K200601 — LumiCare Caries Diagnostic Rinse (March 29, 2021)
  • K193447 — Vista Dyes (March 11, 2020)
  • K060330 — SEE-IT CARIES DETECTOR (April 7, 2006)
  • K030807 — CARIES INDICATOR (June 9, 2003)
  • K012733 — CARIES DETECTOR (September 14, 2001)
  • K994368 — AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS (March 14, 2000)
  • K982105 — ORAL POTENTIAL METER (OPM) (September 16, 1998)
  • K973200 — CARIES STAIN (November 6, 1997)
  • K964430 — PULPDENT SNOOP (January 17, 1997)