Owl Dental Lab, Inc.
Country not established
- Devices
- 5
What Owl Dental Lab, Inc. makes
Owl Dental Lab, Inc. manufactures custom-fitted oral appliances, including the Owl Night Guard, designed to prevent teeth grinding and jaw clenching during sleep.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance process. Owl Dental Lab, Inc. is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
Owl Night Guard Ref K253641
510(k) 510(k)
Company details
- DUNS number
- 125242583
Frequently asked questions
How many devices does Owl Dental Lab, Inc. have in the registry?
The registry currently lists 5 devices for Owl Dental Lab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Owl Dental Lab, Inc.'s devices?
Among its 5 most recently registered devices, Owl Dental Lab, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Owl Dental Lab, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Owl Dental Lab, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Owl Dental Lab, Inc. in the registry?
The most recently registered devices listed for Owl Dental Lab, Inc. include Owl Night Guard 1, Owl Impression Kit 1 and Owl Night Guard.