FDA device listing
Discontinued - Supersede to PXABCC - Cover Cap, AFS,Drill Extender,External 3.5mm Angled Abutment, Hexed,External 4.0mm…
FDA device listing 1670523110 · Precision One Medical
Key facts
| Proprietary names | Discontinued - Supersede to PXABCC - Cover Cap, AFS,Drill Extender,External 3.5mm Angled Abutment, Hexed,External 4.0mm Angled Abutment, Hexed,Ratchet,Starter Drill |
|---|---|
| Owner/operator | Precision One Medical |
| Owner/operator number | 10042281 |
| Product codes | DZE |
| Device names | DZE - Implant, Endosseous, Root-Form |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3640 |
| Review panels | Dental |
| Registered establishments | Precision One Medical, PRECISION ONE MEDICAL |
| Establishment registrations | 3009201148, 3017980266 |
| FEI numbers | 3009201148, 3017980266 |
| Establishment operations | Contract 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