D.B.I. America Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What D.B.I. America Corp. makes
D.B.I. America Corp. manufactures ultrasonic dental instruments, including the Maxisonic family and Swift ultrasonic scalers, as well as the MRS-400, MAXI 400, MRSL-400, and MAXI 400L models. These devices are designed for periodontal and dental cleaning procedures, using ultrasonic vibrations to remove plaque and calculus from teeth and gum surfaces.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) pathway. These instruments are intended for use in dental offices and clinics within the United States.
Catalogue
Maxisonic Family And Swift Ultrasonic Scaler Ref K051910
510(k) 510(k)Mrs-400, Maxi 400, Mrsl-400, Maxi 400l Ref K981990
510(k) 510(k)
Frequently asked questions
How many devices does D.B.I. America Corp. have in the registry?
The registry currently lists 2 devices for D.B.I. America Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list D.B.I. America Corp.'s devices?
Among its 2 most recently registered devices, D.B.I. America Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do D.B.I. America Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for D.B.I. America Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from D.B.I. America Corp. in the registry?
The most recently registered devices listed for D.B.I. America Corp. include MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER and MRS-400, MAXI 400, MRSL-400, MAXI 400L.