FDA device listing
SimpliShade Self-Adhesive Flow,Vertise Flow
FDA device listing 1604022113 · SYBRON DENTAL SPECIALTIES, INC.
Key facts
| Proprietary names | SimpliShade Self-Adhesive Flow,Vertise Flow |
|---|---|
| Owner/operator | SYBRON DENTAL SPECIALTIES, INC. |
| Owner/operator number | 9029565 |
| Premarket submissions | K103351 |
| Product codes | EBC, EBF |
| Device names | EBC - Sealant, Pit And Fissure, And Conditioner, EBF - Material, Tooth Shade, Resin |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3690, 872.3765 |
| Review panels | Dental |
| Registered establishments | Kerr Corporation, Kerr Italia, S.r.l., SDS de Mexico S. de R.L. de C.V. |
| Establishment registrations | 2024312, 8020994, 9680845, 3012477813 |
| FEI numbers | 2024312, 1000231788, 3000368601, 3012477813 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract 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