Triton

Cleanser, Root Canal

Inter-Med / Vista Dental

The following data is part of a premarket notification filed by Inter-med / Vista Dental with the FDA for Triton.

Pre-market Notification Details

• Device ID: K211813
• 510k Number: K211813
• Device Name: Triton
• Classification: Cleanser, Root Canal
• Applicant: Inter-Med / Vista Dental 2200 South Street Racine, WI 53404
• Contact: Brett Arand
• Correspondent: Brett Arand; Inter-Med / Vista Dental 2200 South Street Racine, WI 53404
• Product Code: KJJ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-11
• Decision Date: 2021-08-18