FDA device listing
Advantage Arrest Silver Diamine Fluoride 38% and FluoriMax 2.5% Sodium Fluoride Varnish Convenience Kit
FDA device listing 1873387023 · Elevate Oral Care
Key facts
| Proprietary names | Advantage Arrest Silver Diamine Fluoride 38% and FluoriMax 2.5% Sodium Fluoride Varnish Convenience Kit |
|---|---|
| Owner/operator | Elevate Oral Care |
| Owner/operator number | 10041046 |
| Product codes | PHR |
| Device names | PHR - Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3260 |
| Review panels | Dental |
| Registered establishments | ELEVATE ORAL CARE, LLC |
| Establishment registrations | 3009603151 |
| FEI numbers | 3009603151 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database