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510(k) K951813

CARIES DETECTOR by Kuraray Co. — Product Code LFC

K951813 is an FDA 510(k) premarket notification submitted by Kuraray Co. for the device "CARIES DETECTOR". The FDA issued a decision of Substantially Equivalent on July 11, 1995. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Kuraray Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
April 18, 1995
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 Kuraray Co.

  • K990040 — CLEARFIL SE BOND (February 4, 1999)
  • K933030 — PANAVIA 21 (February 24, 1994)
  • K925383 — PHOTO CLEARFIL OPAQUER (January 28, 1993)
  • K925404 — CLEARFIL PORCELAIN BOND ACTIVATOR (January 11, 1993)
  • K912708 — CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM (August 20, 1991)
  • K912707 — CLEARFIL LINER BOND SYSTEM (August 20, 1991)
  • K910424 — TEETHMATE-F (April 3, 1991)
  • K900690 — CLEARFIL VENEER BOND KIT (April 13, 1990)
  • K897027 — TEETHMATE-A (March 14, 1990)
  • K890123 — CLEARFIL CR INLAY (March 31, 1989)

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