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510(k) K211813

Triton by Inter-Med / Vista Dental — Product Code KJJ

K211813 is an FDA 510(k) premarket notification submitted by Inter-Med / Vista Dental for the device "Triton". The FDA issued a decision of Substantially Equivalent on August 18, 2021. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2021
Date Received
June 11, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances for product code KJJ

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  • K241354 — Sealer Solvent (August 27, 2024)
  • K201785 — EPIEN Dental Cleanser (September 9, 2021)
  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K162311 — Straumann PrefGel (March 7, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)

FDA data resources