FDA device listing
3.5mm Custom Temporary Abutment, 1mm Height,3.5mm Custom Temporary Abutment, 3mm Height,4.5mm Custom Temporary Abutment…
FDA device listing 1425178543 · Precision One Medical
Key facts
| Proprietary names | 3.5mm Custom Temporary Abutment, 1mm Height,3.5mm Custom Temporary Abutment, 3mm Height,4.5mm Custom Temporary Abutment, 1mm Height,4.5mm Custom Temporary Abutment, 3mm Height,BioHorizons Internal Implant,Custom Temporary Abutment Sleeve,Discontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'd,Discontinued - 3.5mm Cover Cap, Machined,Discontinued - 3.5mm Regular Emergence Angled Abutment… |
|---|---|
| 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