Primotec LLC
United Statesfrom the FDA registration address FDA FEI 3004491043
- Devices
- 181
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Primotec LLC makes
Primotec LLC manufactures temporary dental crowns and bridges, custom-made removable occlusal splints, ceramic dental appliance fabrication materials, and non-noble dental casting alloys. Their portfolio includes a single product line, PREMIOtemp, designed for short-term restorative and protective dental applications.
The company’s devices are classified as Class II and Unclassified (U) under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Primotec LLC is based in the United States.
Catalogue
Search and filter all 181 devicesShowing 1-50 of 181
Company details
- FDA FEI number
- 3004491043
- DUNS number
- 153454736
- Address
- 215 Westport Ave, Norwalk, CT, 06851
Frequently asked questions
How many devices does PRIMOTEC LLC have in the registry?
The registry currently lists 181 devices for PRIMOTEC LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list PRIMOTEC LLC's devices?
Among its 50 most recently registered devices, PRIMOTEC LLC has devices listed in FDA GUDID (50 devices).
What risk classes do PRIMOTEC LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for PRIMOTEC LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from PRIMOTEC LLC in the registry?
The most recently registered devices listed for PRIMOTEC LLC include PREMIOtemp PM-Multi-B2-98x16, PREMIOtemp PM-Multi-A3-98x16, PREMIOtemp PM-Multi-A3-98x20 and PREMIOtemp PM-Mono-A1-98x20.