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510(k) K012733

CARIES DETECTOR by Kuraray Medical, Inc. — Product Code LFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2001
Date Received
August 14, 2001
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

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  • K100328 — CLEARFIL MAJETY POSTERIOR (March 5, 2010)
  • K092281 — CLEARFIL MAJESTY POSTERIOR PLT (October 27, 2009)
  • K081583 — CLEARFIL SA CEMENT (July 28, 2008)
  • K071169 — CLEARFIL MAJESTY POSTERIOR PLT (June 20, 2007)
  • K070325 — CLEARFIL MAJESTY ESTHETIC PLT (March 21, 2007)
  • K062409 — K-ETCHANT GEL (November 8, 2006)
  • K061906 — CLEARFIL CERAMIC PRIMER (September 28, 2006)

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  • K060330 — SEE-IT CARIES DETECTOR (April 7, 2006)
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  • 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)