Cleared Traditional

Vista Rinse, Vista Rinse Plus (K193409) - FDA 510(k) Clearance

K193409 · Inter-Med/Vista Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
275d
Days
-
Risk

K193409 is an FDA 510(k) clearance for the Vista Rinse, Vista Rinse Plus. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on September 9, 2020 after a review of 275 days - an extended review cycle.

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. Standard predicate reliance. 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 K193409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date September 09, 2020
Days to Decision 275 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
148d slower than avg
Panel avg: 127d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 40
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