FDA Approved vs Cleared

There is a big difference between “FDA approved” and “FDA cleared”. The FDA has 3 classifications for devices and medications; Class 1 (over the counter anti-snoring devices), Class 2 (dental implants, apnea devices, etc..) and Class 3 (heart valves, implanted parts, devices that are life sustaining and are complex devices that can be life threatening but if their benefits outweigh the risks) and the FDA will approve them if they

Class 1 and 2 medical devices are generally “cleared” by the FDA, which means the manufacturer demonstrated that their product is “substantially equivalent to another legally marketed device” that already has FDA clearance. The cleared products are called a predicate.  We have embedded some applications and approvals so you can see how dental companies consistently reference others in their application and rely on approval of these predecessors.  We have not found any dental devices, software, materials that fall into the Class 3 category

Note that “FDA cleared” does not validate a product or mean that a dental prosthesis will fit with great accuracy. You can click on the first image to read about the process in detail on the FDA website.

 


In the second image, you can search a device, manufacturer, or materials to see exactly how the application was submitted and the FDA’s response to the application

 


ABUTMENT SOFTWARE

3Shape Abutment Designer

K151455

ORTHODONTIC SOFTWARE

CEREC Ortho Software

K171122

3Shape Ortho Software

K152086

IMPLANT SOFTWARE

Sicat 1.0

K090119

Sicat 1.2

K103723

Simplant

K033849

3shape Implant Studio

K141570

3Shape Implant Studio 2015

K152078

APNEA DEVICES

Snore Hook

video
K041184

Optisleep

K153291