FDA device listing
033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr,033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr,033.532S…
FDA device listing 1632477839 · INSTITUT STRAUMANN AG
Key facts
| Proprietary names | 033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr,033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr,033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr,033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr,033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr,033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr,033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr,033.561S Standard… |
|---|---|
| Owner/operator | INSTITUT STRAUMANN AG |
| Owner/operator number | 9005052 |
| Premarket submissions | K122855 |
| 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 | INSTITUT STRAUMANN AG, Straumann Manufacturing, Inc., Straumann Villeret SA |
| Establishment registrations | 9613348, 9614404, 3033781108 |
| FEI numbers | 3002807318, 3004975279, 3033781108 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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