FDA device listing
AB LOC H1mm Conical Platform,AB LOC H2mm Conical Platform,AB LOC H3mm Conical Platform,AB LOC H4mm Conical Platform,AB…
FDA device listing 1464793752 · A.B. DENTAL DEVICES LTD
Key facts
| Proprietary names | AB LOC H1mm Conical Platform,AB LOC H2mm Conical Platform,AB LOC H3mm Conical Platform,AB LOC H4mm Conical Platform,AB LOC H5mm Conical Platform,AB LOC H6mm Conical Platform,Abutment PreFace D11.9mm Conical Platform,Abutment PreFace D11.9mm Narrow Platform,Abutment PreFace D11.9mm Standard Platform,Abutment Screw Conical Platform,Angular Abutment 15º Conical Platform,Angular Abutment 25º Conical… |
|---|---|
| Owner/operator | A.B. DENTAL DEVICES LTD |
| Owner/operator number | 9085481 |
| Premarket submissions | K250806 |
| Product codes | DZE, NHA |
| Device names | DZE - Implant, Endosseous, Root-Form, NHA - Abutment, Implant, Dental, Endosseous |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3630, 872.3640 |
| Review panels | Dental |
| Registered establishments | A.B. DENTAL DEVICES LTD |
| Establishment registrations | 3005663340 |
| FEI numbers | 3005663340 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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