Home / 510(k) Clearances / K193447

510(k) K193447

Vista Dyes by Inter-Med/Vista Dental Products — Product Code LFC

K193447 is an FDA 510(k) premarket notification submitted by Inter-Med/Vista Dental Products for the device "Vista Dyes". The FDA issued a decision of Substantially Equivalent on March 11, 2020. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Inter-Med/Vista Dental Products has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2020
Date Received
December 13, 2019
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 Inter-Med/Vista Dental Products

  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K170101 — Valiant Curing Light (June 8, 2017)

Other clearances for product code LFC

  • K222560 — BlueCheck™ Caries Detection & Monitoring (May 16, 2023)
  • K200601 — LumiCare Caries Diagnostic Rinse (March 29, 2021)
  • 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)
  • K964430 — PULPDENT SNOOP (January 17, 1997)

FDA data resources