Cleared Traditional

V-Mix (K193357) - FDA 510(k) Clearance

K193357 · Inter-Med/Vista Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
324d
Days
-
Risk

K193357 is an FDA 510(k) clearance for the V-Mix. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on October 23, 2020 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Inter-Med/Vista Dental Products devices

Submission Details

510(k) Number K193357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2019
Decision Date October 23, 2020
Days to Decision 324 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 127d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 40
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K193357.
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K200330 · Pac-Dent, Inc. · Jul 2020