FDA device listing
Breeze by Dry&Store,DryBoost,Dry-Brik by Dry&Store,Dry Brik II,Dry Caddy by Dry&Store,Dry Disc by…
FDA device listing 1869773605 · EAR TECHNOLOGY CORPORATION
Key facts
| Proprietary names | Breeze by Dry&Store,DryBoost,Dry-Brik by Dry&Store,Dry Brik II,Dry Caddy by Dry&Store,Dry Disc by Dry&Store,DryDome,Dry&Store Global II,Zephyr by Dry&Store |
|---|---|
| Owner/operator | EAR TECHNOLOGY CORPORATION |
| Owner/operator number | 9007312 |
| Premarket submissions | K972776 |
| Product codes | ESD |
| Device names | ESD - Hearing Aid, Air-Conduction, Prescription |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.3300 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | EAR TECHNOLOGY CORPORATION |
| Establishment registrations | 1056339 |
| FEI numbers | 1000140463 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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