FDA device listing
PreXolid Abutment Screw 2.10mm Hex1.20mm ASMR,PreXolid Abutment Screw 2.10mm Hex1.23mm ASPM,PreXolid Abutment Screw…
FDA device listing 1521570205 · ECLECTIC INC.
Key facts
| Proprietary names | PreXolid Abutment Screw 2.10mm Hex1.20mm ASMR,PreXolid Abutment Screw 2.10mm Hex1.23mm ASPM,PreXolid Abutment Screw 2.10mm Hex1.74mm ASSR,PreXolid Abutment Screw 2.20mm Hex1.74mm ASSM,PreXolid Abutment Screw 2.30mm Hex1.20mm ASAS,PreXolid Abutment Screw 2.30mm Hex1.23mm ASPR,PreXolid Abutment Screw 2.30mm Hex1.27mm ASDS,PreXolid CAD/CAM Abutment 10.00mm P1MRX,PreXolid CAD/CAM Abutment 10.00mm… |
|---|---|
| Owner/operator | ECLECTIC INC. |
| Owner/operator number | 10091703 |
| Premarket submissions | K240725 |
| Product codes | NHA |
| Device names | NHA - Abutment, Implant, Dental, Endosseous |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3630 |
| Review panels | Dental |
| Registered establishments | ECLECTIC INC. |
| Establishment registrations | 3029820793 |
| FEI numbers | 3029820793 |
| Establishment operations | 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