Submission Details
| 510(k) Number | K211813 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Triton
Aug 2021
Decision
68d
Days
—
Risk
About This 510(k) Submission
K211813 is an FDA 510(k) clearance for the Triton, a Cleanser, Root Canal, submitted by Inter-Med / Vista Dental (Racine, US). The FDA issued a Cleared decision on August 18, 2021, 68 days after receiving the submission on June 11, 2021. This device falls under the Dental review panel.
Device Classification
| Product Code | KJJ — Cleanser, Root Canal |
| Device Class | — |
Manufacturer
Similar Devices — KJJ Cleanser, Root Canal
All 40
K250279 · Belport Company, Inc., Gingi-Pak
· Jul 2025
K241354 · Inter-Med, Inc.
· Aug 2024
K201785 · Epien Medical, Inc.
· Sep 2021
K193357 · Inter-Med/Vista Dental Products
· Oct 2020
K193409 · Inter-Med/Vista Dental Products
· Sep 2020
K200330 · Pac-Dent, Inc.
· Jul 2020