FDA device listing
ADIN UNIFIT DENTAL IMPLANT SYSTEM,Screw retained abutments for UniFit dental implants (straight TMA 1-5mm, angled TMA…
FDA device listing 1704616640 · ADIN DENTAL IMPLANT SYSTEMS Ltd
Key facts
| Proprietary names | ADIN UNIFIT DENTAL IMPLANT SYSTEM,Screw retained abutments for UniFit dental implants (straight TMA 1-5mm, angled TMA 17-30 deg 2.5-4mm),Single TMA Cementing Cone,TMA Cementing Cone,Touareg UniFit Dental Implants ( 3.5-6mmD 6-18mmL),UniFit Cement retained abutments (straight, angled 15, angled 25),UniFit Flat Connection Abutments (2mm, 4mm),UniFit Healing Abutment 3.5-5.5mmD 2-6mmL,UniFit… |
|---|---|
| Owner/operator | ADIN DENTAL IMPLANT SYSTEMS Ltd |
| Owner/operator number | 10028570 |
| Premarket submissions | K223714 |
| 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 | ADIN DENTAL IMPLANT SYSTEMS LTD. |
| Establishment registrations | 3007518363 |
| FEI numbers | 3007518363 |
| Establishment operations | Complaint File Establishment, 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