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510(k) K791133

ABCOR CARIES DETECTOR MONITOR by Abcor, Inc. — Product Code LFC

K791133 is an FDA 510(k) premarket notification submitted by Abcor, Inc. for the device "ABCOR CARIES DETECTOR MONITOR". The FDA issued a decision of Substantially Equivalent on August 28, 1979. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1979
Date Received
June 18, 1979
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 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)
  • K102821 — DISCOVRED (March 11, 2011)
  • 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)

FDA data resources