Wykle Research, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 2020703
- Devices
- 89
- Registrations
- FDA
- FDA recalls
- 0
What Wykle Research, Inc. makes
Wykle Research, Inc. manufactures dental materials and tools, including dental amalgam capsules for mixing alloy, glass ionomer dental cement, and single-use dental wedges. The capsules vary by spill resistance, set time, and alloy type, while the wedges come in specific sizes and colors for dental procedures. Powder-based dental amalgam and pre-mixed cement formulations are also part of the portfolio.
The company’s products are regulated under FDA Class I and Class II classifications, with some devices listed via 510(k) premarket notifications and others under the FDA’s Unique Device Identifier (UDI) system. The portfolio appears in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
Search and filter all 89 devicesShowing 1-50 of 89
Company details
- FDA FEI number
- 2020703
- Address
- 2222 EAST COLLEGE PARKWAY, CARSON CITY, NV, 89706
Frequently asked questions
How many devices does WYKLE RESEARCH, INC. have in the registry?
The registry currently lists 89 devices for WYKLE RESEARCH, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list WYKLE RESEARCH, INC.'s devices?
Among its 50 most recently registered devices, WYKLE RESEARCH, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do WYKLE RESEARCH, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for WYKLE RESEARCH, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from WYKLE RESEARCH, INC. in the registry?
The most recently registered devices listed for WYKLE RESEARCH, INC. include Original D Capsules 1 Spill Extra Fast Set 50 count 61133-03, Wykalloy Capsules 3 Spill 500 count 73500, ANA 70 Capsules 2 Spill 450 count 1113400 and ANA 2000 Capsules 1 Spill 50 count 1173000.