Nieusma R & D, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Nieusma R & D, Inc. makes
Nieusma R & D, Inc. manufactures sterile dental barrier sleeves and drapes designed for infection control in dental procedures. The products include pre-sterilized sleeves in sizes such as 60mm x 1650mm and 100mm x 2200mm, as well as drapes for dental use.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Dental Sani-Sleeve Sterile 60mm X 1650mm #1101 Ref K892881
Regimes: 510(k) Registry: 510(k)Dental Sani-Sleeve Sterile 100mm X 2200mm #1102 Ref K892882
Regimes: 510(k) Registry: 510(k)Sani-Sleeve Drape For Dental Use Ref K885299
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nieusma R & D, Inc. have in the registry?
The registry currently lists 3 devices for Nieusma R & D, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nieusma R & D, Inc.'s devices?
Among its 3 most recently registered devices, Nieusma R & D, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Nieusma R & D, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nieusma R & D, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Nieusma R & D, Inc. in the registry?
The most recently registered devices listed for Nieusma R & D, Inc. include DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101, DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 and SANI-SLEEVE DRAPE FOR DENTAL USE.