FDA device listing
Breeze,Breeze Self-Adhesive Resin Cement
FDA device listing 1883094375 · SYBRON DENTAL SPECIALTIES, INC.
Key facts
| Proprietary names | Breeze,Breeze Self-Adhesive Resin Cement |
|---|---|
| Owner/operator | SYBRON DENTAL SPECIALTIES, INC. |
| Owner/operator number | 9029565 |
| Premarket submissions | K060698 |
| Product codes | EMA |
| Device names | EMA - Cement, Dental |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3275 |
| Review panels | Dental |
| Registered establishments | Kerr Italia, S.r.l., SDS de Mexico S. de R.L. de C.V. |
| Establishment registrations | 8020994, 9680845 |
| FEI numbers | 1000231788, 3000368601 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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