Not currently registered with FDA under this name
Avalon Biomed, Inc.
Bradenton, FL, United States. Named as applicant on 3 dental 510(k) clearances between 2012 and 2016. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32012–2016
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Avalon Biomed, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Sep 2016 | K161239 | MTA2.2 MATERIAL | KIF Root Canal Filling Resin |
| 11 Jun 2014 | K140955 | MTA2.1 MATERIAL | KIF Root Canal Filling Resin |
| 11 Dec 2012 | K122892 | MTA2 ROOT AND PULP MATERIALS | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: NuSmile, Ltd. (3), Ultradent Products, Inc. (2).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.