North American Orthodontic Laboratories, Inc.
Country not established
- Devices
- 1
What North American Orthodontic Laboratories, Inc. makes
North American Orthodontic Laboratories, Inc. manufactures dental impression materials, specifically KROMALGIN, which is used for capturing precise molds of teeth and oral structures for orthodontic treatment planning and appliance fabrication.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use within the United States.
Catalogue
Kromalgin Impression Material Ref K964177
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does North American Orthodontic Laboratories, Inc. have in the registry?
The registry currently lists 1 device for North American Orthodontic Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list North American Orthodontic Laboratories, Inc.'s devices?
Among its 1 most recently registered device, North American Orthodontic Laboratories, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do North American Orthodontic Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for North American Orthodontic Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from North American Orthodontic Laboratories, Inc. in the registry?
The most recently registered devices listed for North American Orthodontic Laboratories, Inc. include KROMALGIN IMPRESSION MATERIAL.