Home / 510(k) Clearances / K030807

510(k) K030807

CARIES INDICATOR by Confi-Dental Products Co. — Product Code LFC

K030807 is an FDA 510(k) premarket notification submitted by Confi-Dental Products Co. for the device "CARIES INDICATOR". The FDA issued a decision of Substantially Equivalent on June 9, 2003. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Confi-Dental Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2003
Date Received
March 13, 2003
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 Confi-Dental Products Co.

  • K030743 — ETCHANT 40% (May 9, 2003)
  • K955329 — RESILIENCE M5 PROTECTION PLUS (March 28, 1996)
  • K955328 — CONFI-BOND (March 28, 1996)
  • K954988 — CRYSTALLESSENCE (March 8, 1996)
  • K952930 — DENTRAY II PLUS TRAY ADHESIVE (September 8, 1995)
  • K946307 — CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 26, 1995)
  • K940546 — GRANITEC IONOMER RESIN CEMENT (April 29, 1994)
  • K936070 — TREND SET 2 PLUS (February 4, 1994)
  • K935714 — CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 21, 1994)
  • K933199 — CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL (January 6, 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)
  • K102821 — DISCOVRED (March 11, 2011)
  • K060330 — SEE-IT CARIES DETECTOR (April 7, 2006)
  • 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)

FDA data resources