FDA device listing
17 Screw type Angular Abutment,Abutments Plastic for Casting with Titanium Base & Hex,Anatomic Angular Abutment,Anatomic…
FDA device listing 1963479786 · S.G.S. International Ltd
Key facts
| Proprietary names | 17 Screw type Angular Abutment,Abutments Plastic for Casting with Titanium Base & Hex,Anatomic Angular Abutment,Anatomic Angular Abutment for 7PN,Anatomic Straight Abutment,Anatomic Straight PEEK Abutment,Angular Abutment,Ball Attachment,Ball Attachment for P7N,Cover Screw,Healing Cap,Healing Cap for P7N,Long Angular Abutment,Narrow Angular Abutment for 7PN,Narrow Healing Cap,Narrow Healing Cap… |
|---|---|
| Owner/operator | S.G.S. International Ltd |
| Owner/operator number | 10048289 |
| Premarket submissions | K133362 |
| 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 | S.G.S. INTERNATIONAL LTD |
| Establishment registrations | 3011545243 |
| FEI numbers | 3011545243 |
| 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