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510(k) K973200

CARIES STAIN by Parkell, Inc. — Product Code LFC

K973200 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "CARIES STAIN". The FDA issued a decision of Substantially Equivalent on November 6, 1997. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Parkell, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Parkell, Inc.

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K210259 — Parkell Self-Adhesive Cement (January 20, 2022)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K190930 — SmarTemp X1 (September 5, 2019)
  • K182296 — HyperFil-LV (December 14, 2018)
  • K172176 — Parkell Universal Adhesive (November 21, 2017)
  • K151518 — BRUSH&BOND PLUS (September 18, 2015)
  • K142848 — EAZY PRIMER (February 24, 2015)
  • K132115 — ABSOLUTE DENTIN 2 (June 25, 2014)
  • K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (April 12, 2012)

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

FDA data resources