FiteBac Antimicrobial Cavity Cleanser
FDA 510(k) K200614 · Largent Health, LLC
510(k) numberK200614
Submission
- Device name
- FiteBac Antimicrobial Cavity Cleanser
- Applicant
- Largent Health, LLC
Marietta, GA, US - Received
- March 9, 2020
- Decision date
- June 25, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
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| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
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Questions and answers
When was FiteBac Antimicrobial Cavity Cleanser cleared by the FDA?
FiteBac Antimicrobial Cavity Cleanser (K200614) received a 510(k) decision of Substantially Equivalent on June 25, 2020, 108 days after the submission was received.
What is the product code of K200614?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.