Cleared Special

Triton (K211813) - FDA 510(k) Clearance

K211813 · Inter-Med / Vista Dental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
68d
Days
-
Risk

K211813 is an FDA 510(k) clearance for the Triton. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Inter-Med / Vista Dental (Racine, US). The FDA issued a Cleared decision on August 18, 2021 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inter-Med / Vista Dental devices

Submission Details

510(k) Number K211813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date August 18, 2021
Days to Decision 68 days
Submission Type Special
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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 10
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K211813.
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EPIEN Dental Cleanser
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V-Mix
K193357 · Inter-Med/Vista Dental Products · Oct 2020
Vista Rinse, Vista Rinse Plus
K193409 · Inter-Med/Vista Dental Products · Sep 2020
RC-Prime Root Canal Preparation Cream
K200330 · Pac-Dent, Inc. · Jul 2020