Dental Components, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dental Components, Inc. makes
Dental Components, Inc. manufactures dental-grade water purification systems, including the BIOFREE line, designed to eliminate microbial contamination in dental unit waterlines. Their portfolio also includes standalone water purifiers tailored for dental office use, ensuring safe and compliant water supply for procedures.
The company’s products fall under FDA Class I medical devices, requiring 510(k) clearance for market authorisation. These devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards. The manufacturer operates from the United States.
Catalogue
Biofree Ref K033925
Regimes: 510(k) Registry: 510(k)Dci Water Purifier Ref K971727
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dental Components, Inc. have in the registry?
The registry currently lists 2 devices for Dental Components, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dental Components, Inc.'s devices?
Among its 2 most recently registered devices, Dental Components, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dental Components, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dental Components, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dental Components, Inc. in the registry?
The most recently registered devices listed for Dental Components, Inc. include BIOFREE and DCI WATER PURIFIER.