Smile Horizons, Inc.
Country not established
- Devices
- 1
What Smile Horizons, Inc. makes
Smile Horizons, Inc. manufactures an interface bonding system, designed for securing dental prosthetics or orthodontic attachments to natural teeth or implants. The system includes adhesive interfaces and bonding agents tailored for dental applications, ensuring stable and durable connections in restorative or corrective procedures.
The company’s interface bonding system is classified as Class II under FDA regulations and requires 510(k) clearance. The product is listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards. The manufacturer is based in the United States.
Catalogue
Interface Bonding System Ref K896769
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smile Horizons, Inc. have in the registry?
The registry currently lists 1 device for Smile Horizons, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smile Horizons, Inc.'s devices?
Among its 1 most recently registered device, Smile Horizons, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Smile Horizons, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Smile Horizons, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smile Horizons, Inc. in the registry?
The most recently registered devices listed for Smile Horizons, Inc. include INTERFACE BONDING SYSTEM.