FDA device listing
Drills,GATES,LARGO
FDA device listing 1016583361 · DENTSPLY SIRONA INC
Key facts
| Proprietary names | Drills,GATES,LARGO |
|---|---|
| Owner/operator | DENTSPLY SIRONA INC |
| Owner/operator number | 2511302 |
| Product codes | DZA |
| Device names | DZA - Drill, Dental, Intraoral |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4130 |
| Review panels | Dental |
| Registered establishments | DENTSPLY LLC, DENTSPLY NORTH AMERICA LLC, MAILLEFER INSTRUMENTS HOLDING SARL, RECHERCHES TECHNIQUES DENTAIRES (R.T.D.), TULSA DENTAL PRODUCTS LLC |
| Establishment registrations | 2320721, 2515379, 8031010, 3001226627, 3006186796 |
| FEI numbers | 2515379, 1000185904, 1000554802, 3001226627, 3006186796 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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