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510(k) K973200

CARIES STAIN by Parkell, Inc. — Product Code LFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1997
Date Received
August 26, 1997
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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Other clearances for product code LFC

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  • 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)
  • K964430 — PULPDENT SNOOP (January 17, 1997)