FDA device listing
1.2 mL Plastic Syringe,5 mL Plastic Syringe,Capillary Tips,Deliver-Eze Irrig. & Evac. Kit,Endo-Eze Irrig. Tips,Endo-Eze…
FDA device listing 1585923125 · ULTRADENT PRODUCTS, INC.
Key facts
| Proprietary names | 1.2 mL Plastic Syringe,5 mL Plastic Syringe,Capillary Tips,Deliver-Eze Irrig. & Evac. Kit,Endo-Eze Irrig. Tips,Endo-Eze Tips,Hemostatic Delivery Syringes,Micro 20g tips,Micro Capillary Tips,NaviTip,NaviTip FX Tips,Skini Syringes,SST Surgical Suction Tip,TriAway Adaptor,Ultradent Syringe Covers |
|---|---|
| Owner/operator | ULTRADENT PRODUCTS, INC. |
| Owner/operator number | 1718962 |
| Product codes | EIC |
| Device names | EIC - Syringe, Periodontic, Endodontic, Irrigating |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | Ultradent Products Inc. |
| Establishment registrations | 1718912 |
| FEI numbers | 1718912 |
| Establishment operations | Contract Manufacturer, 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