Island Dental Lab, Inc Dba Emerald Dental
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- Devices
- 1
What Island Dental Lab, Inc Dba Emerald Dental makes
Island Dental Lab, Inc. (dba Emerald Dental) manufactures the Emerald Herbst, a fixed orthodontic appliance designed for tooth alignment and jaw correction in pediatric and adolescent patients. This device is intended for intraoral use and is part of a removable or fixed orthodontic treatment system.
The Emerald Herbst falls under FDA Class II regulation and is listed via the 510(k) pathway. The company operates from the United States, where its devices are registered for commercial distribution.
Catalogue
Emerald Herbst Ref K223624
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Island Dental Lab, Inc Dba Emerald Dental have in the registry?
The registry currently lists 1 device for Island Dental Lab, Inc Dba Emerald Dental. Devices recorded under merged duplicate company entries are counted once.
Which registries list Island Dental Lab, Inc Dba Emerald Dental's devices?
Among its 1 most recently registered device, Island Dental Lab, Inc Dba Emerald Dental has devices listed in FDA 510(k) (1 device).
What risk classes do Island Dental Lab, Inc Dba Emerald Dental's devices fall under?
Among its 1 most recently registered device, the classes recorded for Island Dental Lab, Inc Dba Emerald Dental's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Island Dental Lab, Inc Dba Emerald Dental in the registry?
The most recently registered devices listed for Island Dental Lab, Inc Dba Emerald Dental include Emerald Herbst.