Rocky Mountain Orthodontics, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Rocky Mountain Orthodontics, Inc. makes
Rocky Mountain Orthodontics, Inc. manufactures orthodontic accessories, including buccal tubes for wire placement, custom impression trays for dental scans, and adhesive systems like the NorthernLights Orthodontic Bonding System and Orthomite 111 adhesive. Their portfolio also includes bracket pads for comfort and resin-based adhesives and conditioners for bracket application.
The company’s devices are regulated under FDA Class I and Class II classifications, with most products cleared via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Orthodontic Buccal Tube Ref K780205
Regimes: 510(k) Registry: 510(k)Impression Tray Ref K780678
Regimes: 510(k) Registry: 510(k)Northernlights Orthodontic Bonding System Ref K895401
Regimes: 510(k) Registry: 510(k)Orthomite 111 Adhesive Ref K843527
Regimes: 510(k) Registry: 510(k)Adhesive, Bracket And Conditioner Resin Ref K780334
Regimes: 510(k) Registry: 510(k)Orthodontic Bracket Pads Ref K780170
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rocky Mountain Orthodontics, Inc. have in the registry?
The registry currently lists 6 devices for Rocky Mountain Orthodontics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rocky Mountain Orthodontics, Inc.'s devices?
Among its 6 most recently registered devices, Rocky Mountain Orthodontics, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Rocky Mountain Orthodontics, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Rocky Mountain Orthodontics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rocky Mountain Orthodontics, Inc. in the registry?
The most recently registered devices listed for Rocky Mountain Orthodontics, Inc. include ORTHODONTIC BUCCAL TUBE, IMPRESSION TRAY, NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM and ORTHOMITE 111 ADHESIVE.