The FDA Requirement For Orthodontic Sequential Aligners
Many dental laboratories are receiving requests from dentists regarding the service of providing Orthodontic Clear Aligners. This appears to be a great opportunity to increase profitability with the inclusion of Orthodontic Clear Aligners in your manufacturing services. There does appear to be a tremendous interest by the patients for this treatment.
Before you jump in and start offering this device, please understand what the FDA’s classification of this device and their requirements to be distributing and marketing them exists.
The FDA Product Classification for Orthodontic Clear Aligners is NXC and listed as a Device Class 2 that requires a 510(k) Clearance to be able to legally manufacture and distribute. This product classification position is clearly stated by the FDA and has requirements beyond just using the 3Shape Clear Aligner Studio. In manufacturing these devices, the dental laboratory must manufacture under their own 510(k) or be a Contract Manufacturer for a 510(k) holder. This requirement is similar to those for Sleep Apnea Devices that are also a Class 2 device requiring a 510(k).