FDA device listing
Inclusive Laboratory Basal Screw (5-pack) compatible with: Straumann Tissue Level RN/WN synOcta,Inclusive Laboratory…
FDA device listing 2060208079 · PRISMATIK DENTALCRAFT, INC.
Key facts
| Proprietary names | Inclusive Laboratory Basal Screw (5-pack) compatible with: Straumann Tissue Level RN/WN synOcta,Inclusive Laboratory Basal Screw (5-pack) compatible with: Straumann Tissue Level RN/WN synOcta,Inclusive Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level RN synOcta,Inclusive Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level WN synOcta,Inclusive Titanium Abutment 4.5… |
|---|---|
| Owner/operator | PRISMATIK DENTALCRAFT, INC. |
| Owner/operator number | 10043585 |
| Premarket submissions | K141211 |
| 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 | PRISMATIK DENTALCRAFT, INC. |
| Establishment registrations | 3011649314 |
| FEI numbers | 3011649314 |
| Establishment operations | Complaint File Establishment, 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