Unisplint Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Unisplint Corp. makes
Unisplint Corp. manufactures oral hygiene devices, including dental arch bars and oral sponges designed for intraoral use. These products are intended for temporary or supportive applications in dental or oral health procedures.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Products are listed in the U.S. market under FDA jurisdiction.
Catalogue
Oral Sponge Ref K830675
Regimes: 510(k) Registry: 510(k)Dental Arch Bar Ref K820944
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unisplint Corp. have in the registry?
The registry currently lists 2 devices for Unisplint Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unisplint Corp.'s devices?
Among its 2 most recently registered devices, Unisplint Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Unisplint Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Unisplint Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unisplint Corp. in the registry?
The most recently registered devices listed for Unisplint Corp. include ORAL SPONGE and DENTAL ARCH BAR.