Glenwood, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Glenwood, LLC makes
Glenwood, LLC manufactures dental handpieces designed for endodontic and periodontal procedures, including the IMPACT AIR 45 series. These devices are pneumatic-driven tools used for drilling, cutting, and shaping in oral healthcare applications.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is registered in the United States, where the manufacturer is based.
Catalogue
Impact Air 45 Handpiece For Endodontic Use Ref K972375
Regimes: 510(k) Registry: 510(k)Impact Air 45 Handpiece For Periodontal Use Ref K972376
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Glenwood, LLC have in the registry?
The registry currently lists 2 devices for Glenwood, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glenwood, LLC's devices?
Among its 2 most recently registered devices, Glenwood, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Glenwood, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Glenwood, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Glenwood, LLC in the registry?
The most recently registered devices listed for Glenwood, LLC include IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE and IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE.